Development of 13C-Retinol Isotope Dilution Techniques
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 3
- 主要终点
- Total body vitamin A stores (micromoles of vitamin A)
研究概览
简要总结
Women of reproductive age had their vitamin A stores estimated by retinol isotope dilution and then were given vitamin A supplements near the US vitamin A RDA or placebo for 42(USA) or 60 (Indonesia) days, after which retinol isotope dilution was repeated and the change in vitamin A stores was determined in each group to estimate how much vitamin A is needed to maintain nutrient balance in these women.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Participants blinded (Indonesian), double blinded (USA)
入排标准
- 年龄范围
- 19 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Normal nutritional status (BMI 18.5-25)
排除标准
- •Significant clinical illness
研究组 & 干预措施
Vitamin A supplement
Subjects receive a vitamin A supplement containing 175 or 525 micrograms of vitamin A as retinyl palmitate daily
干预措施: Vitamin A supplement (Dietary Supplement)
Placebo
Subjects receive an oil placebo containing no vitamin A
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Total body vitamin A stores (micromoles of vitamin A)
时间窗: Baseline and after 42 to 60 days
Change in total body stores of vitamin A before and after intervention, measured by retinol isotope dilution
Total vitamin A liver reserves (micromoles vitamin A per gram liver)
时间窗: Baseline and after 42 to 60 days
Change in total liver reserves of vitamin A before and after intervention, measured by retinol isotope dilution
次要结局
未报告次要终点