The Prevalence of Vitamin D Insufficiency in Primary School Children and Comparison of the Effect of Calcium-Vitamin D-Fortified Milk, -Orange Juice and Calcium-Vitamin D Supplement
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 585
- 主要终点
- Serum Levels of 25hydroxy Vitamin D(25(OH)D)Compared to the Due Control Group
研究概览
简要总结
This study is conducted in two phases. At the first phase, the prevalence of vitamin D insufficiency in primary school-children in Tehran is determined during the cold seasons of 2008. Then, the efficacy of calcium-vitamin D-fortified milk, -orange juice and supplement is compared in six selected primary schools.
详细描述
At the first step, serum 25-(OH)D, PTH(parathyroid hormone), osteocalcin, bone alkaline phosphatase, calcium, phosphorous, and magnesium is evaluated. Anthropometric and dietary intake data is also collected. In the second phase, we have 6 experimental groups: (1) plain milk; (2) calcium-vitamin D-fortified milk (containing 500 mg Ca and 100 IU vitamin D/200 mL package); (3) plain orange juice; (4) fortified orange juice containing equal amounts of calcium and vitamin D as fortified milk; (5) calcium-vitamin D supplement (500 mg calcium and 200 IU vitamin D); and (6) placebo. Each group consists of 40-60 children (9-11 years) from both sexes. All above-mentioned biochemical, anthropometric and dietary intake data is collected both in the beginning and in the end of interventional period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 9 Years 至 11 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 9-11 years
- •Being healthy (no apparent clinical disease)
- •Informed consent signed by child's parent(s)
排除标准
- •Subjects receiving vitamin D, calcium or omega-3 supplement
- •Unwillingness to continue the study
- •Subjects with type 1 diabetes, allergy, kidney disorders
结局指标
主要结局
Serum Levels of 25hydroxy Vitamin D(25(OH)D)Compared to the Due Control Group
时间窗: 10 weeks
Serum level of 25(OH)D was determined using competitive protein binding assay (CPBA) method.
次要结局
未报告次要终点
研究者
Tirang R. Neyestani
associate professor
National Nutrition and Food Technology Institute
