Vitamin D Supplementation Requirement in Obese Subjects
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Mean Level of 25(OH)D
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo
Half of subjects will be randomized to the placebo group.
干预措施: placebo (Drug)
Vitamin D3
This is the study group that receives Vitamin D supplementation.
干预措施: Vitamin D3 (Drug)
结局指标
主要结局
Mean Level of 25(OH)D
时间窗: Week 8
Vitamin D (25(OH)D) level at Month 2.
次要结局
未报告次要终点