Comparison of the Efficacy of Vitamin D-fortified Bread Versus Vitamin D Supplement in Healthy Adults: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- 25-hydroxyvitamin D (nmol/L)
研究概览
简要总结
The aim of this study is to evaluate the efficacy of daily intake of fortified bread with vitamin D on serum 25-hydroxyvitamin D level, glycemic and lipidemic status in healthy subjects compared to vitamin D supplement.
详细描述
Sixty apparently healthy subjects will be selected. Participants who are receiving vitamin D, calcium or omega-3 supplements within the last three months will be excluded. Subjects will be assigned randomly to one of the three intervention groups: 1.fortified bread+placebo,2. plain bread+vitamin D supplements,3. plain bread+placebo. Each participant will consume 50 g of bread and supplement or placebo every day for 2 months.
At the first and last visits, dietary and laboratory assessments will be performed for all subjects. Primary outcomes are improvement in vitamin D status and secondary outcome is improvement of glycemic and lipidemic markers and prevention of problems related to hypovitaminosis D.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •20 to 50 years
- •healthy subjects
- •no receiving vitamin D or omega-3 supplement in past 3 months
排除标准
- •receiving vitamin D or omega-3 supplement during the study
研究组 & 干预措施
fortified bread
daily intake of fortified bread (1000IU vitamin D per 50 g) plus placebo
干预措施: fortified bread (Dietary Supplement)
supplement
daily intake of plain bread (50 g) plus supplement (1000 IU per tablet)
干预措施: supplement (Dietary Supplement)
placebo
daily intake of plain bread plus placebo
干预措施: placebo (Dietary Supplement)
结局指标
主要结局
25-hydroxyvitamin D (nmol/L)
时间窗: 8 weeks
次要结局
- serum glucose (mg/dL)(8 weeks)
- serum total cholesterol (mg/dL)(8 weeks)
- serum LDL(8 weeks)
- serum triglyceride (mg/dL)(8 weeks)
- serum PTH (pg/mL)(8 weeks)
- serum HDL (mg/dL)(8 weeks)
研究者
Tirang R. Neyestani, Ph.D.
Professor
National Nutrition and Food Technology Institute