NCT00570856终止4 期
Clinical Trial of Effectiveness of Folic Acid Therapy on Homocysteine Level and Carotid Intima-Media Thickness After Kidney Transplantation
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 60
- 主要终点
- plasma level of total homocysteine (tHcy)
研究概览
简要总结
To see the effect of Folic acid supplementation after kidney transplantation on plasma total homocysteine level and carotid intimal-media thickness
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •having hyperhomocysteinemia(tHcy>12.5 µmol/L in men and 11.5 µmol/L in women )
- •No evident history of CVD
- •no evidence of cigarette smoking
- •not participating in other clinical studies on evaluation of cardiac diseases and
- •not taking any lipid lowering treatment
- •not being pregnant or breast feeding a baby(women)
- •Having HIV or viral hepatitis infections.
排除标准
- •unstable condition of the transplanted kidney (Cr> 3 mg/dl, BUN > 50 mg/dl)
- •Cyclosporine (CsA) intoxication
- •New onset of any severe disease ( such as MI, stroke, DM, etc.).
研究组 & 干预措施
1
Experimental
Folic acid supplementation
干预措施: Folic acid (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
plasma level of total homocysteine (tHcy)
时间窗: 6 months
次要结局
- carotid intima-media thickness (cIMT)(6 months)
研究者
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