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| Name | Class |
|---|---|
| Ohio State University | OTHER |
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This is a pilot randomized controlled trial of lower vs. higher dose vitamin D supplementation in D-deficient asthmatic children, to determine necessary sample sizes for outcome measures in a larger multisite study, and to examine possible relationships and effect sizes between various biological markers that may be important to the pathophysiology of childhood asthma.
Aims of the study are to:
An estimated up to 120 youth meeting eligibility criteria will be screened for vitamin D deficiency, and if found deficient, will be offered enrollment in this study.
Eligible children who assent and whose parent/guardian consent to participate will be randomized to low dose vs. higher dose vitamin D to take across a 3-month period of time. Blood, questionnaires, and pulmonary function tests will be obtained at baseline and end of study. Weekly phone calls will check on any questions or concerns the participant or their family may have.
Aims and Hypotheses:
Aim I: Evaluate effect sizes for relationships between omega-FA and vitD biomarkers, pre- and post- low and higher dose vitamin D supplementation, in diet, immune function, and asthma severity.
Aim II: Characterize changes in innate and adaptive immune function and inflammatory responses in asthmatic D-deficient youth at baseline and after vitD supplements, by O6:O3FA status and vitD dose.
Exploratory: Compute effect sizes/odds ratios for differences in pulmonary function, self-reported asthma severity, depressive symptoms, hospitalization/ED visits, and medication changes based on treatment group.
Effect sizes will be calculated for all continuous outcome variables by:
Effect Size (ES) = Average of the post-test scores - Average of the pre-test scores Average standard deviation
Odds ratios for the categorical asthma severity variable will be computed through logistic regression by treatment group with no covariates.
Examine differences in pulmonary function tests, self-reported asthma severity, depressive symptoms, hospitalization/ED visits, and medication changes based on treatment group. Omega fatty acid intake and allergic status will be included as potentially mediating variables.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vitamin D2 + vitamin D3 | Experimental | Vitamin D2 50,000 IU each week x 4 + vitamin D3 4,000 IU each day for 3 months |
|
| Vitamin D lower dose | Active Comparator | 800 IU vitamin D3 by mouth each day for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D2 + vitamin D3 | Drug | higher dose vitamin D |
|
| Measure | Description | Time Frame |
|---|---|---|
| vitamin D levels | Primary: 1. 25-OH vitamin D (D2, D3): 1.0 ml sample sent to Esoterix Laboratory Services (Austin, TX) through NCH and run via high pressure liquid chromatography (HPLC), Tandem Mass Spectrometry analysis. Samples processed individually, not batched, for intervention study purposes. | change in serum vitamin D level from baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Side Effects Form for Children and Adolescents (SEFCA) | structured interviewer-administered questionnaire inquiring about body systems health and concerns | Baseline, end of week 12 |
| Block Kids 2004 Food Frequency Questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| asthma severity | via pulmonary function tests | baseline, and end of week 12 |
| quality of life | pediatric quality of life questionnaire, including questions about asthma |
Inclusion Criteria:
Exclusion Criteria:
Our definition of a highly effective method of birth control is consistent with ICH Guidance for Industry M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals (April 1997) when used consistently and correctly, such as implants, injectables, oral contraceptives, some intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner. Subjects will also be reminded to use condoms to prevent sexually transmitted diseases and as a second method toward birth control.
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| Name | Affiliation | Role |
|---|---|---|
| Barbara L Gracious, MD | Nationwide Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43210 | United States |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D004872 | Ergocalciferols |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Vitamin D3 | Drug | lower dose vitamin D |
|
|
a questionnaire inquiring how often children eat particular items from different food groups
| baseline, and end of week 12 |
| immune status | key pro-inflammatory and anti-inflammatory cytokines as well as T-cell ratios will be compared before and after vitamin D supplementation | baseline, and end of week 12 |
| Baseline, and end of week 12 |
| omega fatty acid profile | red blood cells will be analyzed for omega fatty acid percentages and ratios of omega 3 fatty acids will be compared to omega 6 fatty acids. | Baseline, and end of week 12 |
| 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 |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |