Efficacy Of Ergocalciferol In Adults According To BMI

Stopped early · Phase 4

Conditions studied: Obesity, Vitamin D Deficiency

In brief

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.

Key facts

Study ID

NCT02435771

Run by

Walter Reed National Military Medical Center

People needed

44

Starts

2011-07-01

Expected to finish

2017-04-01

Last updated by the study team

2017-05-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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
• 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

Where it is running

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

Full record on ClinicalTrials.gov

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