V.I.P. Feasibility Study (Vitamin D Intake Project)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Plasma 25-OH D level
研究概览
简要总结
The purpose of this study is to determine if 14-19 year old African American adolescents are able to take a daily vitamin D supplement daily for about 4 months and how well a daily dose of 400 IU or 2000 IU vitamin D supplement raises their vitamin D blood level.
详细描述
To determine the feasibility of African American teenagers taking a daily vitamin D supplement over a 4 month period in terms of compliance and practical implementation.
To determine the differences in response in blood 25-OH D level between those randomly assigned to taking a 400 IU supplement versus 2000 IU per day and to determine if there are differences in blood 25-OH D level response depending on subject gender and overweight/obese versus healthy-weight status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 14 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy African American Adolescents
排除标准
- •Hypertension
- •Pregnancy
- •Medications that affect study outcome measures
- •Use of other vitamin and/or mineral supplement or herbal supplements
- •Individuals of other races
研究组 & 干预措施
Daily 2000 IU vitamin D supplement
干预措施: 2000 IU Vitamin D3 daily supplement (Dietary Supplement)
Daily Vitamin D supplement 400 IU
干预措施: 400 IU Vitamin D3 supplement (Dietary Supplement)
结局指标
主要结局
Plasma 25-OH D level
时间窗: 3-4 months from baseline to post-testing
次要结局
- Blood pressure(3-4 months from baseline to post-testing)