Efficacy Of Ergocalciferol In Adults According To BMI

NCT02435771 | Terminated Phase 4 DMC

• 1 other identifier: 359128-8
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

• serum 25-hydroxy-vitamin D level

  12 weeks

Study Arms (3)

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

Ergocalciferols DRUG

Treatment 1- 400,000 IU

BMI 25-35; BMI <25; BMI >35

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

MeSH Terms

Conditions

Obesity; Vitamin D Deficiency

Interventions

Ergocalciferols

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Avitaminosis; Deficiency Diseases; Malnutrition

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2013
• First Posted: May 6, 2015
• Study Start: July 1, 2011
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: May 11, 2017

Record last verified: 2017-05

Locations

US (1)