Food-based Solutions for Optimal Vitamin D Nutrition and Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 2
- 主要终点
- The change in vitamin D status measured as serum 25-hydroxyvitamin D
研究概览
简要总结
This project aims at proving the efficacy and safety of food based solutions to prevent vitamin D deficiency in high risk populations of Caucasian and South Asian origin living in Denmark.
详细描述
The study is a 12 week double-blinded, randomised, placebo-controlled food-based intervention trial in a real-life setting. 140 (18-50 y) women in risk of vitamin D deficiency and with Caucasian or South Asian origin. The two ethnic groups of women will each be randomised into two groups. One receiving vitamin D fortified foods and the other receiving the same kind of foods non-fortified. Foods given in the study period are free of charge for the participants and will be handed out every second week. The foods are eggs, yoghurt, cheese and crisp bread.
The study includes a baseline visit and a final visit, at both visits blood samples will be drawn, anthropometrics, muscle strengths, dietary and background questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18-50 year old women
- •Low consumption of fish and fish products
- •Low intake of vitamin D containing supplements
- •No use of sunning facilities
- •No planned sun-holiday between October 2015 and May 2016
排除标准
- •Pregnancy and breastfeeding
- •Menopause
- •Serious diseases (cancer, server liver or kidney insufficiencies, sarcoidosis and other granulomatous diseases) and medicines affecting the vitamin D metabolism (steroids, antiepileptic, thyroid hormones, bisphosphonates, oestrogen).
结局指标
主要结局
The change in vitamin D status measured as serum 25-hydroxyvitamin D
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
Inge Tetens
Professor
Technical University of Denmark