The Vitamin D Dose Response Curve in Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Change in serum 25(OH)D level from baseline.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •obese adults aged 18-65 years and BMI>35
排除标准
- •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
结局指标
主要结局
Change in serum 25(OH)D level from baseline.
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
John F. Aloia, MD
Director, Bone Mineral Research Center
Winthrop University Hospital