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Efficacy Of Ergocalciferol In Adults According To BMI

Primary Purpose

Obesity, Vitamin D Deficiency

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ergocalciferols
Ergocalciferols
Sponsored by
Walter Reed National Military Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

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

Sites / Locations

  • Walter Reed National Military Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

BMI <25

BMI 25-35

BMI >35

Arm Description

Normal BMI

Overweight and obese by BMI

Obese by BMI

Outcomes

Primary Outcome Measures

serum 25-hydroxy-vitamin D level

Secondary Outcome Measures

Full Information

First Posted
May 21, 2013
Last Updated
May 10, 2017
Sponsor
Walter Reed National Military Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02435771
Brief Title
Efficacy Of Ergocalciferol In Adults According To BMI
Official Title
Efficacy Of Ergocalciferol In Adults According To BMI
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
failed to meet enrollment goals
Study Start Date
July 2011 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Walter Reed National Military Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Vitamin D Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BMI <25
Arm Type
Experimental
Arm Description
Normal BMI
Arm Title
BMI 25-35
Arm Type
Experimental
Arm Description
Overweight and obese by BMI
Arm Title
BMI >35
Arm Type
Experimental
Arm Description
Obese by BMI
Intervention Type
Drug
Intervention Name(s)
Ergocalciferols
Intervention Description
Treatment 1- 400,000 IU
Intervention Type
Drug
Intervention Name(s)
Ergocalciferols
Intervention Description
Treatment 2- 800,000 IU
Primary Outcome Measure Information:
Title
serum 25-hydroxy-vitamin D level
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: 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 Chronic liver disease defined by any clinical or a history of serum AST or ALT > 2 times ULN Kidney disease defined as a GFR <60 ml/min Sarcoidosis Any known malignancy Known malabsorption disorder to include inflammatory bowel disease, celiac disease, cystic fibrosis, history of gastric bypass Primary hyperparathyroidism or hypercalcemia, Patients that are pregnant or considering pregnancy. 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alicia L Warnock, MD
Organizational Affiliation
WRNMMC-B
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patrick W Clyde, MD
Organizational Affiliation
WRNMMC-B
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Vinh Mai, MD
Organizational Affiliation
WRNMMC-B
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Verna Parchment
Organizational Affiliation
WRNMMC-B
Official's Role
Study Chair
Facility Information:
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States

12. IPD Sharing Statement

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Efficacy Of Ergocalciferol In Adults According To BMI

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