A Single Wintertime Dose of Vitamin D3 to Prevent Winter Decline in Vitamin D Status in Healthy Adults
Completed · Phase 4 · Has a placebo group
Conditions studied: Vitamin D Deficiency
In brief
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.
Key facts
- Study ID
- NCT01924910
- Run by
- Emory University
- People needed
- 28
- Starts
- 2012-10-01
- Expected to finish
- 2017-07-01
- Last updated by the study team
- 2017-07-13
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy adult (by self-report) between ages 18-65
You may not qualify if…
- reported granulomatous conditions
- history of kidney disease (renal failure, renal stones, serum creatinine over 0.06 ng/mL in the past)
- diabetes
- currently taking anticonvulsants, barbituates, antihypertensives, steroids of any form, or drugs that effect bone metabolism
- history of calcium or bone abnormalities (including osteoporosis)
- primary hyperparathyroidism
- thyrotoxicosis
- Paget's disease
- history of malignancy
- known liver disease
- calcium supplements >1000 mg/day
- complete immobilization
Where it is running
- Emory University Campus — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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