Vitamin D Status After Single Oral Dose of Cholecalciferol in Low Fat Meal Compared to High-fat Meal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Serum Level of Vitamin D3
研究概览
简要总结
The purpose of this study is to evaluate the absorption of dietary supplement of vitamin D3 (cholecalciferol), through the variation of 25 (OH) D levels, as the fat content of the meal associated with the administration of the supplement.
详细描述
Clinical randomized controlled double-blind study with healthy subjects to investigate the effect of low and high fat of meal on absorption of vitamin D supplement. Participants were randomly in two groups according to sex and BMI.
In the same date, each group of participants received a meal and dietary supplement of vitamin D3 (cholecalciferol) after the first blood sample and a urine sample. Others samples were collected in the seventh and fourteenth day after intake the supplement.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Residents of the hospital clinics of Porto Alegre
排除标准
- •Don't drink milk
- •Malnutrition
- •Liver disease
- •Kidney disease or diabetes
- •Use of dietary supplements containing calcium and vitamin D
- •Medications
- •Anticonvulsants
- •Barbiturates, or steroids.
- •Having performed a journey the last four months to locations near the Earth's equatorial plane, due to sun exposure that may have occurred during this period, or vacations planned during the study period.
结局指标
主要结局
Serum Level of Vitamin D3
时间窗: 14 days
次要结局
未报告次要终点