Phase 1 Study of Randomized Clinical Trial Comparing Vitamin C Supplementation Plus Oral Hypoglycemic Drugs Versus Hypoglycemic Drugs Alone on Serum Selenium, Zinc, Copper and Malondialdehyde Levels in Type 2 Diabetes Mellitus and Its Microvascular Complications
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- improving the renal function
研究概览
简要总结
Null hypothesis:
No significant effect of vitamin C 500 mg Supplementation on the severity of micro-vascular complications of type 2 Diabetes Mellitus (DM).
Alternative hypothesis:
There is a significant effect of vitamin C 500mg supplementation on the severity of the micro-vascular complications of type 2DM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of type 2DM
- •patients in good health
- •receiving oral hypoglycemic drugs
排除标准
- •Insulin dependent diabetes
- •receiving vitamin complex
- •renal disease
- •liver disease
研究组 & 干预措施
Type 2DM patients receiving oral hypoglycemic agents alone
this group is the control group who receive oral hypoglycemic agents alone
干预措施: glyburide (Drug)
Vitamin C supplementation plus oral hypoglycemic agents arm
This group will receive vitamin C supplementation 500mg daily for one month and then assessment will done for the patients.
干预措施: Vitamin C (Dietary Supplement)
结局指标
主要结局
improving the renal function
时间窗: the renal function will be measure at day 1 and after one month
vitamin c supplementation act as an antioxidants which reduce the oxidative stress and then can improve the renal function.
次要结局
- Vitamin C can improve the visual fields(the visual field will be assesed at day 1 and after one month)
研究者
Hamdan Zaki Hamdan
Al-Neelain University, Faculty of Medicine, Department of Biochemistry and Molecular biology, Khartoum, Sudan
Al-Neelain University