Vitamin D Supplementation Requirement in Obese Subjects
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 10/14/2017 |
| Start Date: | December 2008 |
| End Date: | August 2011 |
Vitamin D deficiency is common in obese patients. Most of vitamin D supplementation studies
were done with non-obese subjects. This study looks at vitamin D supplementation requirements
in obese patients as compared to non-obese subjects. This study also looks at changes in
vitamin D level in obese patients undergoing medical weight loss. It is thought that obese
patients have vitamin D deficiency through storage of vitamin D in the fat compartment not
readily available for blood measurement. The investigators' hypothesis is that with medical
weight loss vitamin D levels will increase in obese subjects.
were done with non-obese subjects. This study looks at vitamin D supplementation requirements
in obese patients as compared to non-obese subjects. This study also looks at changes in
vitamin D level in obese patients undergoing medical weight loss. It is thought that obese
patients have vitamin D deficiency through storage of vitamin D in the fat compartment not
readily available for blood measurement. The investigators' hypothesis is that with medical
weight loss vitamin D levels will increase in obese subjects.
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.
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.
Inclusion Criteria:
- Healthy men or women between the ages of 18 and 70 years old who are enrolled in our
Weight Management Program with baseline BMI > 30 Kg/m2.
Exclusion Criteria:
- Pregnancy,
- Serum 25(OH)D level greater than 80 nmol/L,
- Hypercalcemia (serum calcium level greater than the upper limit of normal),
- Recent surgery or illness,
- Those with chronic use of medications that influence calcium/vitamin D metabolism such
as anti-convulsants, lithium and steroids. Thiazide diuretics for hypertension will be
acceptable.
- Subjects with sarcoidosis will be excluded.
- Those who do not qualify to participate in the Weight Management Program will be
excluded. They include subjects with active substance abuse and unstable cardiac
disease.
We found this trial at
1
site
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
Click here to add this to my saved trials
