Vitamin D Supplementation Requirement in Obese Subjects
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00996866|
Recruitment Status : Completed
First Posted : October 16, 2009
Last Update Posted : December 15, 2014
|Condition or disease||Intervention/treatment|
|Vitamin D Deficiency||Drug: Vitamin D3 Drug: placebo|
We intend to study changes in serum 25(OH)D level with calorie restricted weight loss in obese subjects. This will be a double dummy, placebo controlled randomized trial. Subjects whose serum 25(OH)D level is below 80 nmol/L will be assigned randomly to either the vitamin D supplemented or the placebo group. Those who are assigned to the placebo group will be weighed on a weekly basis and serum 25(OH)D level will be followed every 8 weeks for a minimum of 16 weeks and extended to the duration of weight loss along with serum calcium level. Changes in serum 25(OH)D level will be obtained with weight loss through restricted caloric intake.
To study the 25(OH)D dose-response curve with vitamin D supplementation in obese subjects, vitamin D supplemented group will receive initial daily vitamin D3 supplementation dose based on their baseline serum 25(OH)D level as described in Methods and Procedures section. Serum 25(OH)D levels will be drawn at 8 weeks and adjustments to the dose will be made based on the an algorithm to achieve serum 25(OH)D levels between 80 and 140 nmol/L. The dose-response curve obtained at 8 weeks will be compared to the one already established with non-obese subjects. Serum 25(OH)D level will be obtained at 16 weeks and compared with the data available from non-obese subjects.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Vitamin D Supplementation Requirement in Obese Subjects|
|Study Start Date :||December 2008|
|Primary Completion Date :||June 2011|
|Study Completion Date :||August 2011|
Placebo Comparator: Placebo
Half of subjects will be randomized to the placebo group.
The placebo group will receive sugar pills appearing similar to the vitamin D capsules.
Active Comparator: Vitamin D3
This is the study group that receives Vitamin D supplementation.
Drug: Vitamin D3
Vitamin D supplementation will follow an algorithm for initial vitamin D dosing and for dose changes. Subjects will receive 100 ug/day of vitamin D3 if their 25(OH)D level is less than 50nmol/L and 50 ug/day if their 25(OH)D level is between 50 and 80 ug/day.
- Mean level of 25(OH)D during calorie restricted weight loss from the placebo group. [ Time Frame: baseline and at 8 weeks ]
- Dose response curve (the 'slope' i.e. the ratio of ∆ 25(OH)D/ initial vitamin D3 dose) in vitamin D supplemented group. [ Time Frame: 8 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00996866
|United States, New York|
|Winthrop University Hospital|
|Mineola, New York, United States, 11501|
|Principal Investigator:||John Aloia,, MD||Winthrop-Unviersity Hospital|