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A Single Wintertime Dose of Vitamin D3 to Prevent Winter Decline in Vitamin D Status in Healthy Adults

NCT01924910 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2017-07-13

No results posted yet for this study

Summary

The purpose of this study is to determine if a single dose of vitamin D administered orally in the fall will provide adequate vitamin D in healthy individuals for the duration of the winter, during which vitamin D levels are known to decrease. The investigators are also interested in finding out if this level of vitamin D will provide adequate levels for the remainder of the year. While the benefits of once-yearly vitamin D administration are clear for patients with osteoporosis, osteomalacia, rickets, and other conditions associated with vitamin D deficiency and high bone turn-over, studies have not been performed in which high doses of vitamin D were used to prevent the seasonal decline of vitamin D concentrations in healthy individuals. These findings could provide evidence to support vitamin D administration to healthy individuals in the wintertime to improve health outcomes, and provide the basis for additional studies in both healthy and sick populations.

Conditions

  • Vitamin D Deficiency

Interventions

DIETARY_SUPPLEMENT

250,000 IU cholecalciferol as single, oral dose

250,000 IU cholecalciferol (vitamin D3) provided as a single oral dose.

DIETARY_SUPPLEMENT

Placebo

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Vin Tangpricha, MD, PhD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-12-31
Completion
2017-07-31

Countries

  • United States

Study Locations

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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 NCT01924910 on ClinicalTrials.gov