Community Interventional Trial (CITFOMIST) to Study the Efficacy and Compliance of Different Degrees of Vitamin D Fortified Milk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6,000
- 试验地点
- 1
- 主要终点
- Compliance with milk consumption
研究概览
简要总结
The cluster randomized trial (CITFOMIST) was conducted on 15-19-year old guidance and high school students of both genders from different districts of Tehran, the Iranian capital, in winter 2011. The 36 schools enrolled in this study were randomly assigned to receive one of the three groups of milk -- whole milk, milk that contained 600 IU Vit D/1000cc, milk that contained 1000 IU Vit D /1000cc -- for a 30-day period. In order to study the effect of vitamin D-fortified milk on the circulating concentrations of 25(OH)D, a serum vitamin D levels were checked in a subgroup before and after the intervention.
详细描述
The cluster randomized trial (CITFOMIST) was conducted on 15-19-year old guidance and high school students of both genders from different districts of Tehran, the Iranian capital, in winter 2011.
The 36 schools enrolled in this study were randomly assigned to receive one of the three groups of milk -- whole milk, milk that contained 600 international unit (IU) Vit D/1000cc (120IU), milk that contained 1000 IU Vit D /1000cc (200IU)-- for a 30-day period. In order to study the effect of vitamin D-fortified milk on the circulating concentrations of 25(OH)D, a serum vitamin D levels were checked in a subgroup before and after the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •15-19-year old guidance and high school students of both genders from different districts of Tehran, the Iranian capital
排除标准
- •Those taking vitamin D supplements
- •Those with underlying disease affecting bone health
- •Those taking medication affecting bone metabolism
- •Those taking fortified products on a regular basis
- •Those following special diets
研究组 & 干预措施
Male Guidance School
Non-Fortified Milk 120IU Milk 200IU Milk
干预措施: 120 IU milk (Dietary Supplement)
Male Guidance School
Non-Fortified Milk 120IU Milk 200IU Milk
干预措施: 200 IU Milk (Dietary Supplement)
Male Guidance School
Non-Fortified Milk 120IU Milk 200IU Milk
干预措施: Non-Fortified Milk (Dietary Supplement)
Female Guidance
Non-fortified Milk 120IU Milk 200IU Milk
干预措施: 120 IU milk (Dietary Supplement)
Female Guidance
Non-fortified Milk 120IU Milk 200IU Milk
干预措施: 200 IU Milk (Dietary Supplement)
Female Guidance
Non-fortified Milk 120IU Milk 200IU Milk
干预措施: Non-Fortified Milk (Dietary Supplement)
Male Highschool
Non-Fortified Milk 120IU Milk 200IU Milk
干预措施: 120 IU milk (Dietary Supplement)
Male Highschool
Non-Fortified Milk 120IU Milk 200IU Milk
干预措施: 200 IU Milk (Dietary Supplement)
Male Highschool
Non-Fortified Milk 120IU Milk 200IU Milk
干预措施: Non-Fortified Milk (Dietary Supplement)
Female Highschool
Non-Fortified Milk 120IU Milk 200IU Milk
干预措施: 120 IU milk (Dietary Supplement)
Female Highschool
Non-Fortified Milk 120IU Milk 200IU Milk
干预措施: 200 IU Milk (Dietary Supplement)
Female Highschool
Non-Fortified Milk 120IU Milk 200IU Milk
干预措施: Non-Fortified Milk (Dietary Supplement)
结局指标
主要结局
Compliance with milk consumption
时间窗: 1 month
次要结局
- Serum 25(OH)D levels(1 month)