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临床试验/NCT00864539
NCT00864539已完成2 期

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

National Nutrition and Food Technology Institute0 个研究点目标入组 585 人开始时间: 2007年11月1日最近更新:
适应症

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

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

发起方
National Nutrition and Food Technology Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tirang R. Neyestani

associate professor

National Nutrition and Food Technology Institute

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