Clinical Trial of Vitamin D Supplementation in Healthy Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Baseline 25 Hydroxy Vitamin D (25OHD) Levels
研究概览
简要总结
This double blind, randomized controlled trial compares two supplemental doses of vitamin D in health adolescents.
详细描述
Vitamin D deficiency is a common problem. Currently, data do not support a recommended vitamin D supplementation dose for health adolescents to maintain normal vitamin D levels. This double blind, randomized controlled 12 week trial compares the use of two supplemental doses of vitamin D in this population.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •11-18 years old
排除标准
- •chronic disease
- •use of medication known to effect bone or vitamin D metabolism
- •abnormal vitamin D or calcium at screening
- •body mass index <5% or >95%
研究组 & 干预措施
Low Dose Vitamin D
Subjects are randomized to take 200 IU vitamin D3 daily in this arm.
干预措施: Supplemental Vitamin D (Drug)
High Dose Vitamin D
Subjects are randomized to take 1000 IU vitamin D3 daily in this arm.
干预措施: Supplemental Vitamin D (Drug)
结局指标
主要结局
Baseline 25 Hydroxy Vitamin D (25OHD) Levels
时间窗: Baseline
25OHD will be drawn at baseline prior to starting vitamin D supplementation.
Follow-up 25OHD Levels
时间窗: 12 weeks
After 11weeks of treatment, repeat 25OHD levels will be drawn to assess subject response to vitamin D supplementation.
次要结局
- Baseline Assessment of Bone Markers(Baseline)
- Assessment of Bone Markers at Follow-up(12 weeks)
研究者
Sarah Pitts
Attending Physician
Boston Children's Hospital