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临床试验/NCT01214356
NCT01214356已完成不适用

Impact of Vitamin D on Diabetic Kidney Disease in African Americans

Medical University of South Carolina2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2010年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
2
主要终点
Change in Urinary Albumin:Creatinine Ratio (ACR)

研究概览

简要总结

This purpose of this project is to evaluate the effectiveness of vitamin D supplementation over 12 months in vitamin D deficient African American adults with type 2 diabetes.

详细描述

Diabetic kidney disease is increasing in prevalence and is associated with significant morbidity and mortality. Health disparities exist in the progression of diabetic kidney disease, with minorities being more affected even when adjusting for treatment, glycemic and hypertensive control, and medical coverage. Secondary prevention of the progression of diabetic kidney disease is hindered by a lack of easily modifiable risk factors. Based on animal and observational human studies, vitamin D deficiency is potentially a novel, modifiable risk factor that may interrupt or delay the progression of diabetic kidney disease through direct effects as well as by helping to ameliorate kidney disease risk factors, such as hyperglycemia, hypertension and inflammation. In addition, based on minorities having a higher prevalence of vitamin D deficiency, it may also potentially impact the differential progression of diabetic kidney disease in minorities. However, clinical trials evaluating the impact of vitamin D supplementation on diabetic kidney disease are lacking. Thus, this pilot study funded as an R03 through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has the following specific aims: (1): To evaluate the impact of vitamin D supplementation (vitamin D3 at 400 IU/d versus 4000 IU/d) on the proportion of individuals with progression of albuminuria over 12 months in a sample of African American participants with vitamin D deficiency in a randomized controlled trial. (2): To identify whether kidney disease risk factors such as blood pressure and glycemic control mediate the impact of vitamin D supplementation on the progression of albuminuria over 12 months in a sample of African American participants with vitamin D deficiency in a randomized controlled trial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • African American race
  • Diagnosis of Type 2 Diabetes
  • Stage 1 or 2 Kidney Disease with detectable microalbuminuria >4.0 (mg/g) 25(OH)D level <20 ng/ml

排除标准

  • Type 1 diabetes
  • -> Stage 3 Kidney Disease, or history of dialysis, kidney transplantation or nephrolithiasis
  • Unable to provide informed consent or contact information
  • Pre-existing calcium or parathyroid condition, including serum calcium >10.2 mg/dL
  • Sarcoidosis, active tuberculosis, or malignancy
  • Known hypersensitivity to vitamin D or any of its analogues and derivatives
  • Current pregnancy or planning to become pregnant in next 15 months

研究组 & 干预措施

Lower Dose Vitamin D

Placebo Comparator

Vitamin D3 supplementation of 400 IU/D or 4000 IU/D with combined calcium carbonate supplementation of 1000 mg/day

干预措施: Vitamin D3 (Dietary Supplement)

Higher Dose Vitamin D

Active Comparator

Vitamin D3 supplementation of 4000 IU/D or 4000 IU/D with combined calcium carbonate supplementation of 1000 mg/day

干预措施: Vitamin D3 (Dietary Supplement)

结局指标

主要结局

Change in Urinary Albumin:Creatinine Ratio (ACR)

时间窗: baseline and 6 months

Urinary Albumin:Creatinine Ratio (ACR) is a well-established, sensitive marker of nephropathy progression (urine albumin (mg/dL) to urine creatinine (g/dL) ratio).

次要结局

  • Decrease in Estimated Glomerular Filtration Rate (eGFR)(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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