Trial to Assess Response to Oral Vitamin D3 Supplementation in Obese Individuals
Completed · Not applicable · Has a placebo group
Conditions studied: Obesity
In brief
This study is an extension of an earlier study of vitamin D supplementation conducted on normal weight individuals by Dr. John Aloia of the Bone Mineral Research Division at Winthrop University Hospital. The investigators plan to compare the response to vitamin D supplementation in obese individuals with the response already measured in normal weight individuals. The same dosing schedule of vitamin supplementation will be used as in the past. The doses used in the past have demonstrated safety in a number of trials, here at Winthrop as well as outside of Winthrop Hospital. Sixty study volunteers are planned for enrollment in the study. The study participants will mainly be recruited from a group of patients who have in the past been enrolled in the weight loss program at Winthrop Hospital. Each participant will be on vitamin D supplementation for a total of 8 weeks. Vitamin D blood levels will be measured before and at the end of the supplementation period. They will then be compared to see the change over time as a result of supplementation.
Key facts
- Study ID
- NCT00960037
- Run by
- Winthrop University Hospital
- People needed
- 57
- Starts
- 2009-01-01
- Expected to finish
- 2011-09-01
- Last updated by the study team
- 2012-06-18
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- obese adults aged 18-65 years and BMI>35
You may not qualify if…
- chronic medical illness (diabetes, malignancy, uncontrolled hypertension, kidney disease)
- subjects who have undergone bariatric surgery or currently enrolled in a medically supervised weight loss program
- BMI < 35
- pregnancy
- use of medication that influences vitamin D metabolism
- history of of hypercalcemia, hypercalciuria, nephrolithiasis
Where it is running
- Winthrop University Hospital — Mineola, New York, United States
Full record on ClinicalTrials.gov
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