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Efficacy Of Ergocalciferol In Adults According To BMI

NCT02435771 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2017-05-11

No results posted yet for this study

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

Interventions

DRUG

Ergocalciferols

Treatment 1- 400,000 IU

DRUG

Ergocalciferols

Treatment 2- 800,000 IU

Sponsors & Collaborators

  • Walter Reed National Military Medical Center

    lead FED

Principal Investigators

  • Alicia L Warnock, MD · WRNMMC-B

  • Patrick W Clyde, MD · WRNMMC-B

  • Vinh Mai, MD · WRNMMC-B

  • Verna Parchment · WRNMMC-B

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2017-04-30
Completion
2017-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02435771 on ClinicalTrials.gov