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临床试验/NCT01412710
NCT01412710已完成不适用

The Effect of Vitamin D Supplementation on Cardiovascular Risk Factors Among Hispanics and African Americans With Type 2 Diabetes

Florida International University1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2011年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
92
试验地点
1
主要终点
Blood Lipid

研究概览

简要总结

The purpose of the present pilot study is to determine the effect of vitamin D supplementation (4000 IU or 6000 IU once daily for 6 months) on reducing heart disease risk and in improving blood glucose control in type 2 Diabetes subjects . The investigators are working with Hispanics and African Americans living in Miami, Florida.

详细描述

Insufficient vitamin D levels have been found in subjects with type 2 diabetes (T2D). Similarly, a negative association between serum vitamin D levels and insulin resistance has been reported in a large sample representative of the adult US population and in subjects at risk for T2D. In addition, a strong association between hypovitaminosis D and hypertriglyceridemia has been demonstrated in studies done in US adult population.

Literature has indicated that subjects with T2D and insulin resistance (IR) are more likely to develop arteriosclerosis and all of the complications related to this condition, such as myocardial infarction and stroke.

These findings have increased the interest about the effect of vitamin D on metabolic abnormalities grouped under the term "cardiovascular disease (CVD) risk factors", which includes hypertension, dyslipidemia, obesity, glucose intolerance, inflammation and T2D which is in itself a risk factor for CVD.

Therefore, the purpose of the present pilot study will be to determine the effect of supplemental vitamin D intake (4000 IU or 6000 IU of Cholecalciferol daily for 6 months) on CVD risk markers and glycemic control; primarily lipid panel, insulin resistance, and glycosylated hemoglobin (A1C), in a sample of Hispanics and African-Americans with T2D and vitamin D insufficiency. If repletion of vitamin D level improves insulin resistance, glycemic control, inflammation, hypertension, dyslipidaemia or kidney functions, it may prevent the development of CVD events and decrease T2D complications.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
30 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2 diabetes
  • African American or Hispanic
  • able to ambulate on their own
  • aged between 30 - 70 years

排除标准

  • Taking Supplemental Vitamin D
  • Pregnant or Lactating women
  • Receiving insulin therapy
  • Not participating in other drug trials
  • HIV/ hepatitis/ cancer/ liver disease/ heart failure/ any recent surgery/ mental illness/ epilepsy/ any GI or malabsorption disorders
  • Kidney failure or on dialysis

研究组 & 干预措施

4000 IU group

Experimental

This group will be given 4000 IU of vitamin D3 once daily, orally for 6 months.

干预措施: Cholecalciferol (Drug)

6000 IU group

Experimental

This group will be given 6000 IU vitamin D3 once daily, orally for 6 months.

干预措施: Cholecalciferol (Drug)

结局指标

主要结局

Blood Lipid

时间窗: Baseline

Total cholesterol will be used as surrogate measures for cardiovascular disease risk.

次要结局

  • Glycemic Control(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatma Ercanli-Huffman

Dr. Fatma G. Huffman

Florida International University

研究点 (1)

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