Efficacy Of Ergocalciferol In Adults According To BMI

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.

Study Overview

• Status: Terminated
• Conditions: Obesity; Vitamin D Deficiency
• Intervention / Treatment: Drug: Ergocalciferols; Drug: Ergocalciferols

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20889
      • Walter Reed National Military Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BMI <25; Normal BMI	Drug: Ergocalciferols; Treatment 1- 400,000 IU; Drug: Ergocalciferols; Treatment 2- 800,000 IU
Experimental: BMI 25-35; Overweight and obese by BMI	Drug: Ergocalciferols; Treatment 1- 400,000 IU; Drug: Ergocalciferols; Treatment 2- 800,000 IU
Experimental: BMI >35; Obese by BMI	Drug: Ergocalciferols; Treatment 1- 400,000 IU; Drug: Ergocalciferols; Treatment 2- 800,000 IU

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Walter Reed National Military Medical Center
• Investigators: Principal Investigator: Alicia L Warnock, MD, WRNMMC-B; Study Director: Patrick W Clyde, MD, WRNMMC-B; Study Chair: Vinh Mai, MD, WRNMMC-B; Study Chair: Verna Parchment, WRNMMC-B

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: May 21, 2013
• First Submitted That Met QC Criteria: April 30, 2015
• First Posted (Estimate): May 6, 2015

Study Record Updates

• Last Update Posted (Actual): May 11, 2017
• Last Update Submitted That Met QC Criteria: May 10, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Ergocalciferols
• Other Study ID Numbers: 359128-8

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No