ISRCTN40736890已完成不适用
A dose-response, double-blind, randomised placebo-controlled trial to estimate the dietary requirement for vitamin D in male and female adolescents aged 14-18 years (The ODIN Study)
niversity of Surrey (UK)0 个研究点目标入组 120 人开始时间: 2014年5月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female
- •2. Aged between 14 and 18 years
- •3. In good health
- •4. Written informed consent from the adolescent (and parent if required)
排除标准
- •1. Currently receiving treatment for medical conditions likely to affect vitamin D metabolism
- •2. Hypercalcaemia (>2.5mmol/l)
- •3. Regular use of sunbeds
- •4. Having a sun holiday one month prior to commencing the trial or plans for a sun holiday within the study period.
- •5. Use of vitamin supplements containing vitamin D ? if the prospective participant agrees to stop vitamin D supplementation to join the study, a washout period of 8 weeks prior to commencing the trial would be acceptable.
- •6. Excessive consumption of alcohol (>14 units per week for females, >21 units per week for males)
- •7. Smoking >10 cigarettes per day
- •8. Those following a weight-reducing diet or under dietary restriction (except vegetarianism)
- •9. Known intolerance/allergy to the constituent ingredients of the daily supplement
- •10. Clinically significant haematological abnormalities other than mild anaemia (Hb<12.0g/dl)
- •11. Active malignancy
- •12. Pregnant or planning a pregnancy during the study period.
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