The Effect of Weight on Vitamin D Dose Response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- To characterize the dose response of 25(OH)D to 1,000, 5,000 or 10,000 IU/day of vitamin D3 for 21 weeks in a group of obese men and women.
研究概览
简要总结
Vitamin D3 is a vitamin that is an essential component of biological regulating systems in humans. Sun exposure is the predominant source of vitamin D3. Previous research has shown that vitamin D3 deficiency is common worldwide. It is especially common in northern countries with long winters due to inadequate sun exposure during winter. In the US, an estimated 36% to 57% of healthy middle-aged to elderly adults have vitamin D3 deficiency. Current research indicates that obesity is associated with a low vitamin D3 level.
详细描述
Obesity is a known risk factor for vitamin D deficiency. Adequate levels of vitamin D are important, not only for bone health, but appear to be important for prevention of certain autoimmune diseases, infections and cancers. Current FDA recommendations for vitamin D intake do not differentiate between lean and obese people. There are no published studies indicating if the 25(OH)D response to a given daily dose of vitamin D is any less in an obese person than a normal weight person. The purpose of this study is to characterize the quantitative relationship between steady state cholecalciferol input and the resulting serum 25 (OH)D concentration in obese subjects. Data obtained in this study will be compared to published normative data for non-obese subjects. Recommendations will be provided for optimal treatment of vitamin D deficiency in obese men and women.
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
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •men aged 19 to 60 with BMI > 30.
- •They will have low (<1,000 IU) usual intake of vitamin D (from milk, multivitamins, supplements, and fortified foods)
排除标准
- •Subjects will not have history of hepatic or renal disease.
- •Subjects will not be taking medications known to affect vitamin D metabolism such as anti-seizure medications and/or corticosteroids.
- •They will not be on hydrochlorothiazide medications which could cause hypercalcemia.
- •They will not have diseases causing malabsorption of vitamin D, such as celiac sprue or small bowel surgeries.
- •Pregnancy is also an exclusion criterion.
研究组 & 干预措施
1,000 IU
1,000 IU/day of vitamin D3
干预措施: cholecalciferol (Dietary Supplement)
5,000 IU
5,000 IU/day of vitamin D3
干预措施: cholecalciferol (Dietary Supplement)
10,000 IU
10,000 IU/day of vitamin D3
干预措施: cholecalciferol (Dietary Supplement)
结局指标
主要结局
To characterize the dose response of 25(OH)D to 1,000, 5,000 or 10,000 IU/day of vitamin D3 for 21 weeks in a group of obese men and women.
时间窗: 21 weeks
次要结局
未报告次要终点