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临床试验/NCT01537809
NCT01537809已完成不适用

The Impact of Vitamin D Supplementation on Cardiometabolic Risk Factors in Schoolchildren

Tufts University2 个研究点 分布在 1 个国家目标入组 691 人开始时间: 2011年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
691
试验地点
2
主要终点
Change in vitamin D levels over six month period

研究概览

简要总结

The purpose of this research is to determine what supplemental doses of vitamin D may be necessary to raise serum levels to optimal levels and how vitamin D supplementation and changes in vitamin D status impact cardiovascular risk factors in schoolchildren.

详细描述

Research suggests that vitamin D, known mainly for its role in bone health, may have other roles in the body and that vitamin D deficiency may contribute to certain chronic diseases, such as cardiovascular disease. Recently, vitamin D has received growing attention due to the increased awareness of possible deficiencies among certain populations at risk of vitamin D deficiency. Most circulating 25-hydroxyvitamin D comes from exposure to UVB rays in natural sunlight. In 2010, the Institute of Medicine issued new recommendations that daily vitamin D intakes should be increased to 600 IU/day for children ages 1-18. However, even with these recommendations in place, roughly 20% of all children are below the recommended 20 ng/mL. Moreover, more than two-thirds of all children have levels below 30 ng/mL, including 80% of Hispanic children and 92% of non-Hispanic black children. Therefore, it is imperative to gain an understanding of: 1) what supplemental doses may be necessary for schoolchildren who are already at a disadvantage in achieving optimal levels of 25(OH)D due to factors such as living at a northern latitude, having high obesity rates, and where a large proportion of the population are Latino or African American; and 2) whether serum concentrations of 25(OH)D over 30 ng/mL in children prevent health risks.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
9 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Subjects in 4th-8th grade
  • Subjects must attend school where study is being conducted
  • Subject and parent/guardian must give assent/consent to participate in study Related Requirements
  • Subjects must complete all study visits (baseline, 3,6 and 12 months)
  • Subjects must agree to be blinded

排除标准

  • Subjects taking glucocorticoids
  • Subjects not in 4th-8th grade
  • Clinical diagnosis of Cystic Fibrosis
  • Clinical diagnosis of Kidney disease
  • Subjects currently taking a vitamin D supplement of >1000 IU/day
  • Subjects diagnosed with Irritable Bowel Syndrome (IBS)
  • Clinical diagnosis of AIDS
  • Clinical diagnosis of Sarcoidosis
  • Clinical diagnosis of Epilepsy

结局指标

主要结局

Change in vitamin D levels over six month period

时间窗: Six months

Subjects will be randomized to receive one of three doses of vitamin D3. Baseline serum 25(OH)D levels will be compared to serum 25(OH)D at 3 and 6 months. Safety Issue?: (FDAAA) No

次要结局

  • measure serum glucose and blood lipids (total cholesterol, HDL, LDL and triglycerides) in connection with changes in vitamin D status(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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