Efficacy Of Ergocalciferol In Adults According To BMI | NCT02435771

Studies
Efficacy Of Ergocalciferol In Adults According To BMI

NCT02435771

Sponsor

Walter Reed National Military Medical Center

Status

Terminated

Last Update Posted

May 11, 2017Actual

Enrollment

44Actual

Phase

Phase 4

Conditions

Obesity
Vitamin D Deficiency

Interventions

Ergocalciferols
Ergocalciferols

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

failed to meet enrollment goals

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Apr 2017Actual

Completion Date

Apr 2017Actual

First Submitted Date

May 21, 2013

First Submission Date that Met QC Criteria

Apr 30, 2015

First Posted Date

May 6, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

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

May 10, 2017

Last Update Posted Date

May 11, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Vitamin D insufficiency is an increasing trend in the United States. According to the NHANES data collection there was a near doubling of patients with vitamin D deficiency in 10 years. Vitamin D deficiency is associated with several adverse outcomes such as increased fractures, certain microbial diseases, cardiovascular diseases, and metabolic dysfunction. The increasing prevalence of vitamin D deficiency has been attributed to the increasing prevalence of obesity. Several studies have shown that obese patients have lower 25-OH vitamin D (25-OHD) levels compared to nonobese patients and obese patients require more vitamin D compared to nonobese patients. The most commonly prescribed medication to replete vitamin D deficiency is oral ergocalciferol. To date, no prospective trials have been published to evaluate a standard protocol in the treatment of vitamin D insufficiency in adults.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BMI <25	Experimental	Normal BMI	Drug: Ergocalciferols
BMI 25-35	Experimental	Overweight and obese by BMI	Drug: Ergocalciferols
BMI >35	Experimental	Obese by BMI	Drug: Ergocalciferols

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ergocalciferols	Drug	Treatment 1- 400,000 IU	BMI 25-35 BMI <25 BMI >35

Measure	Description	Time Frame
serum 25-hydroxy-vitamin D level		12 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Study subjects have to be between the ages of 18 to 65 with a serum 25OHD level less than 20 ng/ml.

Exclusion Criteria:

Participants will be excluded if they have any of the following:
1. Due to the inaccuracies of BMI in patients with increased muscle mass, in group with a BMI 25-35: men with a waist circumference < 90 cm ; women < 80 cm
2. Chronic liver disease defined by any clinical or a history of serum AST or ALT > 2 times ULN
3. Kidney disease defined as a GFR <60 ml/min
4. Sarcoidosis
5. Any known malignancy
6. Known malabsorption disorder to include inflammatory bowel disease, celiac disease, cystic fibrosis, history of gastric bypass
7. Primary hyperparathyroidism or hypercalcemia,
8. Patients that are pregnant or considering pregnancy.
9. Patients taking certain medications such as glucocorticoids, anti-seizure medications such has phenobarbital or phenytoin or patients taking antiviral medications for HIV as these are known to cause vitamin D deficiency
10. Individuals excluded from having a DXA scan

Study participants will be excluded from having a DXA scan if any of the following:

Any amputation of a extremity including toes
If they have a pacemaker, automatic defibrillator, coronary stents or metal suture material in the heart
If they have artificial joints, pins, plate or any other type of metal objects
If they have received contrast material such as barium in the past 7 days
If they have had a nuclear medicine study in the past 3 days

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alicia L Warnock, MD	WRNMMC-B	Principal Investigator
Patrick W Clyde, MD	WRNMMC-B	Study Director
Vinh Mai, MD	WRNMMC-B	Study Chair
Verna Parchment	WRNMMC-B	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Walter Reed National Military Medical Center		Bethesda	Maryland	20889	United States

Type	Date	Date Unknown
Release	Oct 18, 2018
Reset	Nov 14, 2018

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

ID	Term
D002782	Cholestenes
D002776	Cholestanes
D013256	Steroids
D000072473	Fused-Ring Compounds

ID	Term
D009765	Obesity
D014808	Vitamin D Deficiency