NCT01921192Unknown4 期
Effect of Folic Acid, Vitamin B6 and Vitamin B12 in Diabetic Retinopathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- homocysteine
研究概览
简要总结
Homocysteine, a well-known inducer of vascular endothelial cell damage has been associated with extracellular matrix changes. Many studies demonstrated that high levels of this aminoacid in diabetic patients increases significantly the risk of the development of this pathology. This study has been undertaken to investigate the role of homocysteine and its cofactors (folic acid, vitamin B6 and B12) during the progression of the diabetic retinopathy.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diabetic patients with proliferative and non proliferative retinopathy
排除标准
- •Patients with chronic liver disease Patients with kidney disease.
研究组 & 干预措施
Sugar pill
Placebo Comparator
干预措施: Placebo (Drug)
Folic Acid, vit B6 and B12
Active Comparator
干预措施: Folic Acid, vit B6 and B12 (Drug)
结局指标
主要结局
homocysteine
时间窗: 12 months
次要结局
- folic acid(12 months)
研究者
Mariano Malaguarnera
Associate Professor
University of Catania
研究点 (1)
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