drugset / Trial / NCT02435771

Efficacy Of Ergocalciferol In Adults According To BMI

NCT02435771

Phase 4 Terminated 44 enrolled Walter Reed National Military Medical Center
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2011-07
Primary completion
2017-04
Completion
2017-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Ergocalciferol Small molecule 400000 iu Oral
Subject Ergocalciferol Small molecule 800000 iu Oral