Vitamin D Oral Replacement in Asthma | NCT03686150 | Trialant
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Studies Vitamin D Oral Replacement in Asthma NCT03686150 Show options IDeA States Pediatric Clinical Trials Network
Asthma Vitamin D Deficiency Pediatric Obesity Obsolete or Duplicate NCT IDs Not provided
ID Type Description Link U24OD024957 U.S. NIH Grant/Contract
Vitamin D Oral Replacement in Asthma
Vitamin D Oral Replacement in Asthma
IDeA States Pediatric Clinical Trials Network NETWORK
Overall Recruitment Status or Expanded Access Status Completed
First Submission Date that Met QC Criteria Sep 25, 2018
Results First Submitted Date Sep 27, 2022
Results First Submitted that Met QC Criteria Mar 27, 2023
Results First Posted Date Apr 19, 2023 Actual
Certification/Extension (aka Delayed Results) First Submitted Date Not provided
Certification/Extension First Submitted that Passed QC Review Not provided
Certification/Extension First Posted Date Not provided
Last Update Submitted Date Mar 27, 2023
Responsible Party, by Official Title Sponsor
IDeA States Pediatric Clinical Trials Network NETWORK
Name Class National Institutes of Health (NIH) NIH
Has Data Monitoring Committee (DMC) Yes
Pediatric Postmarket Surveillance of a Device Product Not provided
The overall objective of the study is to determine the pharmacokinetics of Vitamin D supplementation in children who have asthma and are overweight or obese.
This study has two parts. In part 1, study participants will be randomized to receive one of four doses of vitamin D supplementation in international units (IU) over at 16-week period: 1) Single 50,000 IU loading dose + 6000 IU daily dose; 2) Single 50,000 IU loading dose + 10,000 IU daily dose: 3) 6000 IU daily dose; or 4) 600 IU daily dose. Based on pharmacokinetic analysis, one of the doses (1-3) will be selected to use in part 2.
In part 2, study participants will be randomized to the dose selected in part 1 or the 600 IU daily dose of vitamin D supplementation to be administered over a 16-week dosing period.
Across both parts, safety of each dose regimen of vitamin D supplementation will be evaluated, and the effectiveness of each dose to achieve a serum level of 25(OH)D greater than or equal to 40 ng/ml will be assessed.
Asthma Vitamin D Deficiency Pediatric Obesity Number of References to an Expanded Access Study Not provided
Target Follow-Up Duration Not provided
No data available
No data is available for this block.
Label Type Description Intervention Names Part 1, Cohort 1 Vitamin D3 oral regimen Experimental Intervention: Vitamin D: Single 50,000 IU loading dose + 6000 IU daily dose
Dietary Supplement: Vitamin D3 oral regimen Part 1, Cohort 2 Vitamin D3 oral regimen Experimental Vitamin D: Single 50,000 IU loading dose + 10,000 IU daily dose
Dietary Supplement: Vitamin D3 oral regimen Part 1, Cohort 3 Vitamin D3 oral regimen Experimental Vitamin D: 6000 IU daily dose
Dietary Supplement: Vitamin D3 oral regimen Part 1, Cohort 4 Vitamin D3 oral regimen Active Comparator Vitamin D: 600 IU daily dose
Dietary Supplement: Vitamin D3 oral regimen Part 2, Cohort A Vitamin D3 oral regimen Experimental Vitamin D: Single 50,000 IU loading dose + 8,000 IU daily doseD
Dietary Supplement: Vitamin D3 oral regimen Part 2, Cohort B Vitamin D oral regimen
Name Type Description Arm Group Labels Other Names Vitamin D3 oral regimen Dietary Supplement Vitamin D3 oral regimens supplementation
Part 1, Cohort 1 Vitamin D3 oral regimen Part 1, Cohort 2 Vitamin D3 oral regimen
Measure Description Time Frame Part 1: Optimal Dosing Level to Use in Part 2 Determine the best vitamin D supplementation level based on PK analysis of participants enrolled in Part 1. The PK of 25(OH)D after vitamin D supplementation in children will be characterized using a 2-compartment population PK model (popPK) with linear absorption and elimination kinetics.
20 weeks Part 2: Proportion of Participants With Vitamin D Levels >= 40 ng/ml Proportion of participants in part 2 who achieve vitamin levels >= 40 ng/ml
16 weeks
Inclusion Criteria:
Body mass index greater than or equal to 85% for age and sex
Physician-diagnosed asthma
Ongoing relationship with asthma provider responsible for asthma care
Serum 25(OH) D level 10 ng/ml to less than 30 ng/ml at screening visit based on local laboratory test
Ability to swallow pills similar in size to the vitamin D preparation to be used
Signed consent form from parent, legal guardian or caregiver and signed assent from participant (as appropriate)
Females of childbearing years must not be pregnant, must not be lactating and must agree to practice adequate birth control method
Child and parent, legal guardian, or caregiver must speak English or Spanish
Exclusion Criteria:
Known diseases of calcium metabolism or the parathyroid
History of renal insufficiency or kidney stones
Known liver failure or history of abnormal liver function tests
History of Williams syndrome, sarcoidosis, or granulomatous disease
Active tuberculosis
Spot urine calcium/creatinine ration greater than 0.37 (calcium and creatinine measured in mg/ml). This can be repeated following adequate hydration
Clinical evidence of rickets
Taking supplemental vitamin D greater than equal to 1000 IU per day
Accepts Healthy Volunteers No
Facility Status City State ZIP Country Contacts Arkansas Children's Hospital Little Rock Arkansas 72202 United States Nemours/Alfred I duPont Hospital for Children
PubMed Identifier Type Citation Retractions Background O'Sullivan BP, James L, Majure JM, Bickel S, Phan LT, Serrano Gonzalez M, Staples H, Tam-Williams J, Lang J, Snowden J; IDeA States Pediatric Clinical Trials Network. Obesity-related asthma in children: A role for vitamin D. Pediatr Pulmonol. 2021 Feb;56(2):354-361. doi: 10.1002/ppul.25053. Epub 2020 Dec 8. Derived Lang JE, Ramirez RG, Balevic S, Bickel S, Hornik CP, Majure JM, Venkatachalam S, Snowden J, O'Sullivan B, James L. Pharmacokinetics of Oral Vitamin D in Children with Obesity and Asthma. Clin Pharmacokinet. 2023 Nov;62(11):1567-1579. doi: 10.1007/s40262-023-01285-9. Epub 2023 Aug 30.
Available IPD Information Not provided
Data will be uploaded to Data and Specimen Hub (DASH) of NICHD
Study Protocol Informed Consent Form (ICF) Anticipated date of data upload is September 2023
A total of 166 study participants consented to be screened for the trial; 112 met eligibility criteria and were randomized onto the trial.
The trial comprised of a Dose Finding part (Part 1) and a Dose Confirming par (Part 2). During Part 1, participants (children) were enrolled and randomized to one of four dose groups at 1:1:1:1 allocation ratio. During Part 2, participants (children) were randomized to one of two dose groups at 2:1 allocation ratio.
ID Title Description FG000 Part 1, Cohort 1 Vitamin D3 Oral Regimen Intervention: Vitamin D: Single 50,000 IU loading dose + 6000 IU daily dose
Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation
FG001 Part 1, Cohort 2 Vitamin D3 Oral Regimen
Title Milestones Reasons Not Completed Overall Study Type Comment Milestone Data STARTED
Baseline Analysis Population Description
No data available
No data is available for this block.
Document Has No Statistical Analysis Plan (SAP) Not provided
Uploaded Document Information Type Includes Protocol Includes SAP Includes ICF Document Label Document Date Document Uploaded Date Document File Name Prot_SAP Yes Yes No Study Protocol and Statistical Analysis Plan Dec 14, 2020
No data available
No data is available for this block.
No data available
No data is available for this block.
Randomized
Intervention Model Description Randomized, parallel arm clinical trial 4 arms in part 1 2 arms in part 2
Active Comparator
Vitamin D: 600 IU daily dose
Dietary Supplement: Vitamin D3 oral regimen
Part 1, Cohort 3 Vitamin D3 oral regimen
Part 1, Cohort 4 Vitamin D3 oral regimen
Part 2, Cohort A Vitamin D3 oral regimen
Part 2, Cohort B Vitamin D oral regimen Kapiolani Medical Center for Women and Children Honolulu Hawaii 96826 United States
University of Louisville Louisville Kentucky 40292 United States
Pennington Biomedical Research Center Baton Rouge Louisiana 70808 United States
University of Mississippi Medical Center Jackson Mississippi 39216 United States
Children's Mercy Hospital Kansas City Missouri 64108 United States
Community Medical Center Missoula Montana 59804 United States
University of Nebraska Medical Center/Children's Hospital and Medical Center Omaha Nebraska 68198 United States
Dartmouth Hospital - Manchester Manchester New Hampshire 03104 United States
University of New Mexico Health Sciences Center Albuquerque New Mexico 87131 United States
Children's Hospital OU Medical Center Oklahoma City Oklahoma 73104 United States
University of South Carolina Columbia South Carolina 29208 United States
University of Vermont Medical Center Burlington Vermont 05401 United States
West Virginia University Morgantown West Virginia 26506 United States
Vitamin D: Single 50,000 IU loading dose + 10,000 IU daily dose
Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation
FG002 Part 1, Cohort 3 Vitamin D3 Oral Regimen Vitamin D: 6000 IU daily dose
Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation
FG003 Part 1, Cohort 4 Vitamin D3 Oral Regimen Vitamin D: 600 IU daily dose
Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation
FG004 Part 2, Cohort A Vitamin D3 Oral Regimen Vitamin D: Single 50,000 IU loading dose + 8,000 IU daily doseD
Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation
FG005 Part 2, Cohort B Vitamin D Oral Regimen Vitamin D: 600 IU daily dose
Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation
FG000 13 subjects
FG001 12 subjects
FG002 11 subjects
FG003 12 subjects
FG004 43 subjects
FG005 21 subjects COMPLETED FG000 11 subjects FG001 10 subjects FG002 10 subjects FG003 12 subjects FG004 42 subjects FG005 18 subjects
NOT COMPLETED FG000 2 subjects FG001 2 subjects FG002 1 subjects FG003 0 subjects FG004 1 subjects FG005 3 subjects
Type Comment Reasons Withdrawal by Subject FG000 1 subjects FG001 1 subjects FG002 1 subjects FG003 0 subjects FG004 1 subjects FG005 2 subjects Physician Decision FG000 1 subjects FG001 0 subjects FG002 0 subjects FG003 0 subjects FG004 Lost to Follow-up FG000 0 subjects FG001 1 subjects FG002 0 subjects FG003 0 subjects FG004
This vitamin D supplementation study was performed in two parts: 1) PK analysis to identify recommended dost for part 2, and 2) assess the effectiveness of the recommended 16-week dosing regimen to achieve serum level of 25(OH)D greater than or equal to 40 ng/mL.
ID Title Description BG000 Part 1, Cohort 1 Vitamin D3 Oral Regimen Intervention: Vitamin D: Single 50,000 IU loading dose + 6000 IU daily dose
Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation
BG001 Part 1, Cohort 2 Vitamin D3 Oral Regimen Vitamin D: Single 50,000 IU loading dose + 10,000 IU daily dose
Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation
BG002 Part 1, Cohort 3 Vitamin D3 Oral Regimen Vitamin D: 6000 IU daily dose
Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation
BG003 Part 1, Cohort 4 Vitamin D3 Oral Regimen Vitamin D: 600 IU daily dose
Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation
BG004 Part 2, Cohort A Vitamin D3 Oral Regimen Vitamin D: Single 50,000 IU loading dose + 8,000 IU daily dose
Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation
BG005 Part 2, Cohort B Vitamin D Oral Regimen Vitamin D: 600 IU daily dose
Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation
BG006 Total Total of all reporting groups
Units Counts Participants BG000 13 BG001 12 BG002 11 BG003 12 BG004 43 BG005 21 BG006 112
Title Description Population Description Parameter Type Dispersion Type Unit of Measure Calculate Percentage Denominator Units Selected Denominators Classes Age, Continuous Mean Standard Deviation years Title Denominators Categories Participants BG000 13 Participants BG001 12 Participants BG002 11 Participants BG003
Sex: Female, Male Count of Participants Participants Title Denominators Categories Participants BG000 13 Participants BG001 12 Participants BG002
Ethnicity (NIH/OMB) Count of Participants Participants Title Denominators Categories Participants BG000 13 Participants BG001 12 Participants BG002
Race (NIH/OMB) Count of Participants Participants Title Denominators Categories Participants BG000 13 Participants BG001 12 Participants BG002
Baseline Body Mass Index (BMI) Mean Standard Deviation kg/m^2 Title Denominators Categories Participants BG000 13 Participants BG001 12 Participants BG002
BMI percentile Count of Participants Participants Title Denominators Categories Participants BG000 13 Participants BG001 12 Participants BG002
Rural-Urban Commuting Area (RUCA) codes The RUCA codes classify US census tract based on measures of urbanization, population density, and daily commuting from the decennial census. The classification contains whole numbers (1-10) used to delineate metropolitan (1-3), micropolitan (4-6), small town (7-9), and rural areas (10).
Count of Participants Participants Title Denominators Categories Participants BG000 13 Participants BG001 12 Participants BG002
Baseline 25(OH)D 25(OH)D = (25-hydroxy vitamin D); Baseline measures were captured at visit 2 (day 0; week 1).
Note: Cohort 1, Cohort A, and Cohort B each one participant with missing 25(OH)D measurement at baseline.
Mean Standard Deviation ng/mL Title Denominators Categories Participants BG000 12 Participants BG001 12 Participants BG002
Baseline 25(OH)D level > 100 ng/mL 25(OH)D = (25-hydroxy vitamin D)
Note: Cohort 1, Cohort A, and Cohort B each had one participant with missing 25(OH) D values at baseline.
Count of Participants Participants Title Denominators Categories Participants BG000 12 Participants BG001 12 Participants BG002
Type Title Description Population Description Reporting Status Anticipated Posting Date Parameter Type Dispersion Type Unit of Measure Calculate Percentage Time Frame Units Analyzed Denominator Units Selected Arm/Group Information Denominators Classes Analyses Primary Part 1: Optimal Dosing Level to Use in Part 2 Determine the best vitamin D supplementation level based on PK analysis of participants enrolled in Part 1. The PK of 25(OH)D after vitamin D supplementation in children will be characterized using a 2-compartment population PK model (popPK) with linear absorption and elimination kinetics.
A total of 263 PK samples from 48 participants were collected in part 1 of the VDORA1 study. For the population PK analysis, 36 samples with missing prior dosing information from 13 participants were excluded, leaving a final analysis population of 44 participants with 227 serum concentrations.
Posted Number IU 20 weeks Serum Concentrations Serum Concentrations ID Title Description OG000 Vitamin D3 Oral Regimen Vitamin D: Single 50,000 IU loading dose + 8,000 IU daily dose
Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation
Units Counts Participants Serum Concentrations
Title Denominators Categories Daily Dose (IU) Single Loading Dose (IU)
Group IDs Group Description Statistical Method Statistical Comment P-Value P-Value Comment Parameter Type Parameter Value Dispersion Type Dispersion Value Confidence Interval Sides Confidence Interval % CI Lower Limit CI Upper Limit CI Lower Limit Comment CI Upper Limit Comment Estimate Comment Tested Non-Inferiority Non-Inferiority Type Non-Inferiority Comment Other Analysis Description Part 1 of this study was to perform a population PK analysis of 25(OH)D after oral administration of Vitamin D in children who are overweight or obese and have asthma. Based on the interim analysis of the VDORA study, the PK of 25(OH)D after Vitamin D supplementation in children was well characterized by a 2-compartment population PK model with linear absorption and elimination kinetics. A loading dose of 50,000 IU followed by a daily dose of 8,000 IU was recommended.
Other This was a population PK analysis of 25(OH)D after oral administration of Vitamin D.
Primary Part 2: Proportion of Participants With Vitamin D Levels >= 40 ng/ml Proportion of participants in part 2 who achieve vitamin levels >= 40 ng/ml
One participant from Cohort A and three participants from Cohort B did not have 25(OH)D measurements at Visit 6 (week 16).
Posted Number 95% Confidence Interval proportion of participants 16 weeks ID Title Description OG000 Part 2, Cohort A Vitamin D3 Oral Regimen Vitamin D: Single 50,000 IU loading dose + 8,000 IU daily dose
Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation
OG001 Part 2, Cohort B Vitamin D Oral Regimen Vitamin D: 600 IU daily dose
Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation
Participant Duration: 30 weeks (2-week screening/run-in; 16-week intervention; 12-week follow-up period)
Using standard definitions of adverse events, adverse events were reported during the intervention and follow-up periods.
All-Cause Mortality Comment Not provided
ID Title Description Deaths (Affected) Deaths (At Risk) Serious Events (Affected) Serious Events (At Risk) Other Events (Affected) Other Events (At Risk) EG000 Part 1, Cohort 1 Vitamin D3 Oral Regimen Intervention: Vitamin D: Single 50,000 IU loading dose + 6000 IU daily dose
Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation
0 13 0 13 11 13 EG001 Part 1, Cohort 2 Vitamin D3 Oral Regimen Vitamin D: Single 50,000 IU loading dose + 10,000 IU daily dose
Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation
0 12 1 12 9 12 EG002 Part 1, Cohort 3 Vitamin D3 Oral Regimen Vitamin D: 6000 IU daily dose
Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation
0 11 1 11 11 11 EG003 Part 1, Cohort 4 Vitamin D3 Oral Regimen Vitamin D: 600 IU daily dose
Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation
0 12 1 12 10 12 EG004 Part 2, Cohort A Vitamin D3 Oral Regimen Vitamin D: Single 50,000 IU loading dose + 8,000 IU daily dose
Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation
0 43 0 43 21 43 EG005 Part 2, Cohort B Vitamin D Oral Regimen Vitamin D: 600 IU daily dose
Vitamin D3 oral regimen: Vitamin D3 oral regimens supplementation
0 21 1 21 14 21
Term Organ System Source Vocabulary Assessment Type Notes Statistical Information Asthma Respiratory, thoracic and mediastinal disorders MedDRA (10.0) Non-systematic Assessment In all cases, this SAE was not related to Vitamin D or study procedure.
EG000 0 affected 13 at risk EG001 1 affected 12 at risk EG002 1 affected 11 at risk EG003 1 affected 12 at risk EG004 Anaphylactic Reaction Immune system disorders MedDRA (10.0) Non-systematic Assessment This SAE was not related to Vitamin D or study procedure.
EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003
Term Organ System Source Vocabulary Assessment Type Notes Statistical Information abdominal discomfort Gastrointestinal disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 1 affected 11 at risk EG003 0 affected 12 at risk EG004 1 affected 43 at risk EG005 0 affected 21 at risk abdominal pain upper Gastrointestinal disorders MedDRA (10.0) Non-systematic Assessment EG000 1 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 acarodermatitis Skin and subcutaneous tissue disorders MedDRA (10.0) Non-systematic Assessment EG000 1 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 acne Skin and subcutaneous tissue disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 adenoidectomy Surgical and medical procedures MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 adenotonsillectomy Surgical and medical procedures MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 alopecia Skin and subcutaneous tissue disorders MedDRA (10.0) Non-systematic Assessment EG000 1 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 amebiasis Infections and infestations MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 anaphylactic reaction Immune system disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 animal scratch Injury, poisoning and procedural complications MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 arthralgia Musculoskeletal and connective tissue disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 arthropod bite Injury, poisoning and procedural complications MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 1 affected 11 at risk EG003 asthenia General disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 asthma Immune system disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 1 affected 11 at risk EG003 asthma Respiratory, thoracic and mediastinal disorders MedDRA (10.0) Non-systematic Assessment EG000 4 affected 13 at risk EG001 3 affected 12 at risk EG002 5 affected 11 at risk EG003 cardiac ablation Surgical and medical procedures MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 cerumen impaction Ear and labyrinth disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 chest cold Respiratory, thoracic and mediastinal disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 chest discomfort General disorders MedDRA (10.0) Non-systematic Assessment EG000 1 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 chills General disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 concussion Injury, poisoning and procedural complications MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 1 affected 12 at risk EG002 0 affected 11 at risk EG003 conjunctivitis Eye disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 conjunctivitis Infections and infestations MedDRA (10.0) Non-systematic Assessment EG000 1 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 constipation Gastrointestinal disorders MedDRA (10.0) Non-systematic Assessment EG000 1 affected 13 at risk EG001 0 affected 12 at risk EG002 1 affected 11 at risk EG003 contusion Injury, poisoning and procedural complications MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 1 affected 11 at risk EG003 coronavirus infection Infections and infestations MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 cough Respiratory, thoracic and mediastinal disorders MedDRA (10.0) Non-systematic Assessment EG000 4 affected 13 at risk EG001 4 affected 12 at risk EG002 5 affected 11 at risk EG003 depression Psychiatric disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 diarrhea Gastrointestinal disorders MedDRA (10.0) Non-systematic Assessment EG000 2 affected 13 at risk EG001 1 affected 12 at risk EG002 0 affected 11 at risk EG003 dizziness Nervous system disorders MedDRA (10.0) Non-systematic Assessment EG000 1 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 dysmenorrhoea Reproductive system and breast disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 dyspnoea Respiratory, thoracic and mediastinal disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 ear infection Infections and infestations MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 2 affected 12 at risk EG002 0 affected 11 at risk EG003 ear injury Injury, poisoning and procedural complications MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 eczema Skin and subcutaneous tissue disorders MedDRA (10.0) Non-systematic Assessment EG000 1 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 emotional disorder of childhood Psychiatric disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 eosinophilic oesophagitis Gastrointestinal disorders MedDRA (10.0) Non-systematic Assessment EG000 1 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 epistaxis Respiratory, thoracic and mediastinal disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 epixtaxis Vascular disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 eye pain Eye disorders MedDRA (10.0) Non-systematic Assessment EG000 1 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 eyelid sensory disorder Eye disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 fall Injury, poisoning and procedural complications MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 1 affected 11 at risk EG003 fatigue General disorders MedDRA (10.0) Non-systematic Assessment EG000 1 affected 13 at risk EG001 0 affected 12 at risk EG002 1 affected 11 at risk EG003 fungal skin infection Infections and infestations MedDRA (10.0) Non-systematic Assessment EG000 1 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 gastritis viral Gastrointestinal disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 1 affected 12 at risk EG002 0 affected 11 at risk EG003 gastroenteritis Gastrointestinal disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 1 affected 11 at risk EG003 gastroenteritis viral Gastrointestinal disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 1 affected 11 at risk EG003 gastrointestinal reflux disease Gastrointestinal disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 groin pain Musculoskeletal and connective tissue disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 headache Nervous system disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 3 affected 12 at risk EG002 3 affected 11 at risk EG003 hidradenitis Skin and subcutaneous tissue disorders MedDRA (10.0) Non-systematic Assessment EG000 1 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 hypersensitivity Immune system disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 influenza Infections and infestations MedDRA (10.0) Non-systematic Assessment EG000 1 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 influenza b virus test positive Investigations MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 insomnia Nervous system disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 iron deficiency anemia Blood and lymphatic system disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 joint injury Injury, poisoning and procedural complications MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 laceration Injury, poisoning and procedural complications MedDRA (10.0) Non-systematic Assessment EG000 1 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 laryngitis Respiratory, thoracic and mediastinal disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 1 affected 12 at risk EG002 0 affected 11 at risk EG003 ligament sprain Injury, poisoning and procedural complications MedDRA (10.0) Non-systematic Assessment EG000 1 affected 13 at risk EG001 0 affected 12 at risk EG002 1 affected 11 at risk EG003 lower respiratory tract congestion Respiratory, thoracic and mediastinal disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 migraine Nervous system disorders MedDRA (10.0) Non-systematic Assessment EG000 1 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 muscle strain Injury, poisoning and procedural complications MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 musculoskeletal discomfort Musculoskeletal and connective tissue disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 musculoskeletal pain Musculoskeletal and connective tissue disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 myalgia Musculoskeletal and connective tissue disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 nasal congestion Respiratory, thoracic and mediastinal disorders MedDRA (10.0) Non-systematic Assessment EG000 2 affected 13 at risk EG001 1 affected 12 at risk EG002 4 affected 11 at risk EG003 nasopharyngitis Infections and infestations MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 1 affected 11 at risk EG003 nasopharyngitis Respiratory, thoracic and mediastinal disorders MedDRA (10.0) Non-systematic Assessment EG000 1 affected 13 at risk EG001 1 affected 12 at risk EG002 1 affected 11 at risk EG003 nausea Gastrointestinal disorders MedDRA (10.0) Non-systematic Assessment EG000 1 affected 13 at risk EG001 1 affected 12 at risk EG002 1 affected 11 at risk EG003 ocular discomfort Eye disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 1 affected 12 at risk EG002 0 affected 11 at risk EG003 oedema peripheral General disorders MedDRA (10.0) Non-systematic Assessment EG000 1 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 oral herpes Infections and infestations MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 oropharyngeal pain Gastrointestinal disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 2 affected 11 at risk EG003 oropharyngeal pain Respiratory, thoracic and mediastinal disorders MedDRA (10.0) Non-systematic Assessment EG000 1 affected 13 at risk EG001 0 affected 12 at risk EG002 1 affected 11 at risk EG003 pain General disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 1 affected 11 at risk EG003 pain in extremity Musculoskeletal and connective tissue disorders MedDRA (10.0) Non-systematic Assessment EG000 1 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 painful respiration Respiratory, thoracic and mediastinal disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 paralysis Nervous system disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 1 affected 11 at risk EG003 paresthesia Nervous system disorders MedDRA (10.0) Non-systematic Assessment EG000 1 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 paronychia Infections and infestations MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 peripheral coldness General disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 pharyngitis streptococcal Respiratory, thoracic and mediastinal disorders MedDRA (10.0) Non-systematic Assessment EG000 1 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 pneumonia Respiratory, thoracic and mediastinal disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 polydipsia Metabolism and nutrition disorders MedDRA (10.0) Non-systematic Assessment EG000 1 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 post procedural discomfort General disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 procedural pain General disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 procedural vomiting Injury, poisoning and procedural complications MedDRA (10.0) Non-systematic Assessment EG000 1 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 pyrexia General disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 rash Skin and subcutaneous tissue disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 2 affected 12 at risk EG002 3 affected 11 at risk EG003 respiratory tract congestion Respiratory, thoracic and mediastinal disorders MedDRA (10.0) Non-systematic Assessment EG000 1 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 respiratory tract infection Respiratory, thoracic and mediastinal disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 1 affected 12 at risk EG002 0 affected 11 at risk EG003 respiratory tract infection viral Respiratory, thoracic and mediastinal disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 1 affected 12 at risk EG002 0 affected 11 at risk EG003 scar excision Surgical and medical procedures MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 1 affected 12 at risk EG002 0 affected 11 at risk EG003 seasonal allergy Respiratory, thoracic and mediastinal disorders MedDRA (10.0) Non-systematic Assessment EG000 1 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 sinusitis Infections and infestations MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 1 affected 12 at risk EG002 0 affected 11 at risk EG003 sinusitis Respiratory, thoracic and mediastinal disorders MedDRA (10.0) Non-systematic Assessment EG000 1 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 sneezing Respiratory, thoracic and mediastinal disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 1 affected 11 at risk EG003 stomatitis Gastrointestinal disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 thermal burning Injury, poisoning and procedural complications MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 tinea pedis Skin and subcutaneous tissue disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 tinnitus Ear and labyrinth disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 tonsillectomy Surgical and medical procedures MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 1 affected 11 at risk EG003 tooth extraction Surgical and medical procedures MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 turbinectomy Surgical and medical procedures MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 turbinoplasty Surgical and medical procedures MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 upper respiratory infection Infections and infestations MedDRA (10.0) Non-systematic Assessment EG000 1 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 upper respiratory infection Respiratory, thoracic and mediastinal disorders MedDRA (10.0) Non-systematic Assessment EG000 1 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 upper respiratory tract infection Infections and infestations MedDRA (10.0) Non-systematic Assessment EG000 1 affected 13 at risk EG001 3 affected 12 at risk EG002 0 affected 11 at risk EG003 upper respiratory tract infection Respiratory, thoracic and mediastinal disorders MedDRA (10.0) Non-systematic Assessment EG000 1 affected 13 at risk EG001 1 affected 12 at risk EG002 1 affected 11 at risk EG003 urine abnormality Renal and urinary disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 urine calcium/creatinine ratio increased Investigations MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 1 affected 12 at risk EG002 0 affected 11 at risk EG003 vessel puncture site bruise Vascular disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 vessel puncture site pain Injury, poisoning and procedural complications MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 viral infection Infections and infestations MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 1 affected 11 at risk EG003 viral upper respiratory tract infection Respiratory, thoracic and mediastinal disorders MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003 vomiting Gastrointestinal disorders MedDRA (10.0) Non-systematic Assessment EG000 1 affected 13 at risk EG001 1 affected 12 at risk EG002 1 affected 11 at risk EG003 vulvovaginal mycotic infection Infections and infestations MedDRA (10.0) Non-systematic Assessment EG000 0 affected 13 at risk EG001 1 affected 12 at risk EG002 0 affected 11 at risk EG003 wheezing Respiratory, thoracic and mediastinal disorders MedDRA (10.0) Non-systematic Assessment EG000 2 affected 13 at risk EG001 1 affected 12 at risk EG002 2 affected 11 at risk EG003 wisdom teeth removal Surgical and medical procedures MedDRA (10.0) Non-systematic Assessment EG000 1 affected 13 at risk EG001 0 affected 12 at risk EG002 0 affected 11 at risk EG003
Are all PI(s) employees of the sponsor? No
Results Disclosure Restriction on PI(s)? No
Title Organization Phone Extension Email Songthip Ounpraseuth University of Arkansas for Medical Sciences 501-686-7233 stounpraseuth@uams.edu
ICF No No Yes Informed Consent Form Nov 2, 2020 Mar 24, 2022
ID Term D001249 Asthma D014808 Vitamin D Deficiency D063766 Pediatric Obesity
ID Term D001982 Bronchial Diseases D012140 Respiratory Tract Diseases D008173 Lung Diseases, Obstructive D008171 Lung Diseases D012130 Respiratory Hypersensitivity D006969 Hypersensitivity, Immediate D006967 Hypersensitivity D007154 Immune System Diseases D001361 Avitaminosis D003677 Deficiency Diseases D044342 Malnutrition D009748 Nutrition Disorders D009750 Nutritional and Metabolic Diseases D009765 Obesity D050177 Overweight D044343 Overnutrition D001835 Body Weight D012816 Signs and Symptoms D013568 Pathological Conditions, Signs and Symptoms
0 subjects
FG005 1 subjects 0 subjects
FG005 0 subjects 12
Participants BG004 43
Participants BG005 21
Participants BG006 112 Title Measurements BG000 12.8 ± 3.1 BG001 12.3 ± 3.4 BG002 11.5 ± 3.6 BG003 12.5 ± 2.9 BG004 12.2 ± 2.5 BG005 11.7 ± 2.6 BG006 12.1 ± 2.8
11
Participants BG003 12
Participants BG004 43
Participants BG005 21
Participants BG006 112 Title Measurements Female BG000 6 BG001 7 BG002 5 BG003 5 BG004 20 BG005 10 BG006 53 Male BG000 7 BG001 5 BG002 6 BG003 7 BG004
11
Participants BG003 12
Participants BG004 43
Participants BG005 21
Participants BG006 112 Title Measurements Hispanic or Latino BG000 5 BG001 2 BG002 2 BG003 1 BG004 7 BG005 3 BG006 20 Not Hispanic or Latino BG000 7 BG001 10 BG002 8 BG003 10 BG004 Unknown or Not Reported BG000 1 BG001 0 BG002 1 BG003 1 BG004
11
Participants BG003 12
Participants BG004 43
Participants BG005 21
Participants BG006 112 Title Measurements American Indian or Alaska Native BG000 0 BG001 0 BG002 0 BG003 0 BG004 3 BG005 1 BG006 4 Asian BG000 0 BG001 1 BG002 1 BG003 0 BG004 Native Hawaiian or Other Pacific Islander BG000 0 BG001 0 BG002 0 BG003 0 BG004 Black or African American BG000 6 BG001 4 BG002 5 BG003 6 BG004 White BG000 4 BG001 5 BG002 3 BG003 5 BG004 More than one race BG000 0 BG001 1 BG002 1 BG003 1 BG004 Unknown or Not Reported BG000 3 BG001 1 BG002 1 BG003 0 BG004
11
Participants BG003 12
Participants BG004 43
Participants BG005 21
Participants BG006 112 Title Measurements BG000 33.9 ± 8.4 BG001 29.7 ± 6.4 BG002 30.1 ± 4.3 BG003 32.2 ± 9.2 BG004 30.8 ± 6.9 BG005 30.3 ± 8.2 BG006 31.0 ± 7.3
11
Participants BG003 12
Participants BG004 43
Participants BG005 21
Participants BG006 112 Title Measurements >= 85th to < 95th BG000 3 BG001 2 BG002 2 BG003 3 BG004 9 BG005 5 BG006 24 >= 95th to < 99th BG000 4 BG001 3 BG002 2 BG003 3 BG004 >= 99th BG000 6 BG001 7 BG002 7 BG003 6 BG004
11
Participants BG003 12
Participants BG004 43
Participants BG005 21
Participants BG006 112 Title Measurements Metropolitan BG000 13 BG001 10 BG002 9 BG003 11 BG004 32 BG005 17 BG006 92 Micropolitan BG000 0 BG001 1 BG002 1 BG003 0 BG004 Small town BG000 0 BG001 1 BG002 1 BG003 1 BG004 Rural BG000 0 BG001 0 BG002 0 BG003 0 BG004
11
Participants BG003 12
Participants BG004 42
Participants BG005 20
Participants BG006 109 Title Measurements BG000 18.3 ± 6.5 BG001 20.8 ± 7.2 BG002 19.0 ± 5.2 BG003 17.6 ± 5.8 BG004 17.7 ± 6.0 BG005 16.3 ± 5.2 BG006 18.0 ± 6.0
11
Participants BG003 12
Participants BG004 42
Participants BG005 20
Participants BG006 109 Title Measurements Yes BG000 0 BG001 0 BG002 0 BG003 0 BG004 0 BG005 0 BG006 0 No BG000 12 BG001 12 BG002 11 BG003 12 BG004
Based on the interim analysis of the VDORA study, the PK of 25(OH)D after Vitamin D supplementation in children was well characterized by a 2-compartment population PK model with linear absorption and elimination kinetics. A loading dose of 50,000 IU followed by a daily dose of 8,000 IU was recommended.
42
OG001 18 Title Denominators Categories Title Measurements OG000 0.786 (0.641 to 0.883) OG001 0 (0 to 0.176)
Group IDs Group Description Statistical Method Statistical Comment P-Value P-Value Comment Parameter Type Parameter Value Dispersion Type Dispersion Value Confidence Interval Sides Confidence Interval % CI Lower Limit CI Upper Limit CI Lower Limit Comment CI Upper Limit Comment Estimate Comment Tested Non-Inferiority Non-Inferiority Type Non-Inferiority Comment Other Analysis Description This is a one-sample test of proportion.
z-test 0.0001 Other This is one-sample test of proportion testing the null hypothesis that the proportion of participants with 25(OH)D level >= 40 ng/mL is 50%.
0 affected
43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 1 affected 21 at risk 0 affected
12 at risk
EG004 1 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 1 affected 43 at risk
EG005 0 affected 21 at risk 1 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 1 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 1 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 1 affected 21 at risk 0 affected
12 at risk
EG004 1 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 1 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 1 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 2 affected 21 at risk 3 affected
12 at risk
EG004 1 affected 43 at risk
EG005 3 affected 21 at risk 0 affected
12 at risk
EG004 1 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 1 affected 43 at risk
EG005 0 affected 21 at risk 1 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 1 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 1 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 1 affected 43 at risk
EG005 1 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 2 affected 21 at risk 3 affected
12 at risk
EG004 2 affected 43 at risk
EG005 2 affected 21 at risk 0 affected
12 at risk
EG004 1 affected 43 at risk
EG005 0 affected 21 at risk 1 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 1 affected 43 at risk
EG005 0 affected 21 at risk 1 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 1 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 1 affected
12 at risk
EG004 1 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 1 affected 43 at risk
EG005 0 affected 21 at risk 1 affected
12 at risk
EG004 1 affected 43 at risk
EG005 0 affected 21 at risk 1 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 1 affected 43 at risk
EG005 0 affected 21 at risk 1 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 1 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 1 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 1 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 1 affected 43 at risk
EG005 0 affected 21 at risk 1 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 2 affected
12 at risk
EG004 3 affected 43 at risk
EG005 1 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 1 affected 43 at risk
EG005 3 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 1 affected 21 at risk 0 affected
12 at risk
EG004 1 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 1 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 1 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 1 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 1 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 1 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 1 affected 43 at risk
EG005 0 affected 21 at risk 1 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 1 affected 43 at risk
EG005 0 affected 21 at risk 1 affected
12 at risk
EG004 1 affected 43 at risk
EG005 1 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 1 affected 21 at risk 1 affected
12 at risk
EG004 1 affected 43 at risk
EG005 2 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 1 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 1 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 2 affected
12 at risk
EG004 1 affected 43 at risk
EG005 1 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 1 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 1 affected 21 at risk 1 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 1 affected
12 at risk
EG004 1 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 1 affected 21 at risk 0 affected
12 at risk
EG004 1 affected 43 at risk
EG005 1 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 3 affected
12 at risk
EG004 0 affected 43 at risk
EG005 1 affected 21 at risk 1 affected
12 at risk
EG004 2 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 1 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 1 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 1 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 1 affected 21 at risk 0 affected
12 at risk
EG004 1 affected 43 at risk
EG005 0 affected 21 at risk 1 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 1 affected 43 at risk
EG005 0 affected 21 at risk 1 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 1 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 1 affected 21 at risk 0 affected
12 at risk
EG004 1 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 1 affected 21 at risk 0 affected
12 at risk
EG004 1 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 1 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 1 affected 21 at risk 1 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 1 affected 43 at risk
EG005 0 affected 21 at risk 2 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 0 affected
12 at risk
EG004 0 affected 43 at risk
EG005 0 affected 21 at risk 1 affected
12 at risk
EG004 1 affected 43 at risk
EG005 1 affected 21 at risk 0 affected
12 at risk
EG004 1 affected 43 at risk
EG005 1 affected 21 at risk 23
BG005 11
BG006 59 33
BG005 18
BG006 86 3
BG005 0
BG006 6 0
BG005 0
BG006 2 1
BG005 0
BG006 1 15
BG005 9
BG006 45 19
BG005 10
BG006 46 2
BG005 1
BG006 6 3
BG005 0
BG006 8 16
BG005 8
BG006 36 18
BG005 8
BG006 52 5
BG005 1
BG006 8 3
BG005 2
BG006 8 3
BG005 1
BG006 4 42
BG005 20
BG006 109