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临床试验/NCT01141192
NCT01141192已完成不适用

The Effect of Vitamin D Supplementation on Glucose Metabolism in Non-Diabetic African American Adults

Augusta University2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2010年1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
48
试验地点
2
主要终点
Fasting glucose level before, mid-way through, and after the vitamin D3 supplement or placebo trial.

研究概览

简要总结

Type 2 diabetes is more common among African Americans than Caucasians. African Americans are also at a higher risk for lower levels of vitamin D compared to other ethnic groups. The investigators don't yet know if there is a connection between not having enough vitamin D and type 2 diabetes in African Americans. Researchers have found that the less vitamin D Caucasians had the higher the chance they would have type 2 diabetes but it is less clear if this is the case for African Americans. The investigators want to better understand how vitamin D status and diabetes risk are linked in African Americans. Also, the investigators want to see if supplementation with vitamin D will improve your blood pressure, blood sugar, & insulin. All of these are in some way related to diabetes. The investigators want to measure changes in blood sugar & blood pressure in people who do not have diabetes with the hope of learning new information to help treat those that do have diabetes.

The investigators hypothesize that vitamin D status is related to diabetes risk measured by hemoglobin A1c (a test of glucose level over time), fasting glucose and insulin in non-diabetic African American adults and that body weight status may affect vitamin D status in response to vitamin D supplements compared to placebo.

详细描述

Participants will be randomly assigned to receive either a 60,000 IU vitamin D3 supplement every four weeks or an inactive placebo. All investigators and the participants will be blinded to the assignment group of each participant until all testing is completed.

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, Investigator)

入排标准

年龄范围
19 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • African American by self-report
  • In good health

排除标准

  • Diagnosis of diabetes
  • Health problems/medication affecting calcium and/or vitamin D metabolism
  • Current use of vitamin/mineral/herbal/nutritional supplements
  • Inability to swallow pills
  • Pregnancy

结局指标

主要结局

Fasting glucose level before, mid-way through, and after the vitamin D3 supplement or placebo trial.

时间窗: 16 weeks

次要结局

  • Serum 25-OH D levels in response to vitamin D3 supplement or placebo across a range of adiposity(16 weeks)

研究者

申办方类型
Other

研究点 (2)

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