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临床试验/NCT01173315
NCT01173315已完成2 期

The Impact of Vitamins and Minerals Supplementation on Neuropathy and Nephropathy Complications in Type 2 Diabetic Patients: a Randomised Clinical Trial

Shahid Beheshti University of Medical Sciences0 个研究点目标入组 75 人开始时间: 2007年6月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
75
主要终点
Evidence of clinically neuropathy confirmed by nerve conduction velocities

研究概览

简要总结

The combination of vitamin and mineral supplementation may improve:

  • glycemic control
  • lipid profile
  • oxidative stress
  • blood pressure
  • nephropathy indices
  • neuropathy indices

详细描述

A total of 75 diabetic patients (39 men and 36 women), aged 36 to 69 years, having diabetes for at least 3 years, was recruited for this study. Type 2 diabetes was defined as fasting plasma glucose 126 mg/dl (two times repeated) or taking oral glucose-lowering agents.Diabetic patients were stratified by sex and randomly assigned to one of the three treatment groups using block randomization procedure. Depending upon the treatment groups, each subject received two capsules per day, 1 with breakfast and 1 with dinner, for a period of 4 months. Each capsule contained one of the following preparations and hence determined the corresponding groups: Group MV: Zinc sulfate and Magnesium oxide (providing 10 mg Zn and 125 mg Mg) and vitamin C (100 mg) and vitamin E (100 mg); Group MVB: both of the above mineral and vitamin supplements plus vitamin B1 (5 mg), vitamin B2 (5 mg), vitamin B6 (5 mg), biotin (50 µg), vitamin B12 (5 µg) and folic acid (0.5 mg); Group P: starch (placebo). All of the study medications, including the placebo, were supplied by Pharmaceutical Sciences Research Center (Tehran University of Medical Sciences, Iran) and were indistinguishable from each other. They were stored at 20-25 0C.

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
Triple (Participant, Care Provider, Investigator)

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 for 3 years

排除标准

  • Resting blood pressure >160/100 mmHg
  • Taking vitamin and/or mineral supplement, thyroid hormones, estrogens, progesterone, diuretics or antihypertensive agents
  • Having history of myocardial infarction and hepatic disease

结局指标

主要结局

Evidence of clinically neuropathy confirmed by nerve conduction velocities

时间窗: 4 months

nerve conduction velocities in the bilateral sural sensory nerves, and peroneal, tibial, median, and ulnar motor nerves with F waves in hands and legs extremity

次要结局

  • nephropathy indices were determined by 3 times urine microalbumin concentration using Enzyme Immuno Assay commercial kit(4 months)

研究者

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