Tocopherols and Alpha Lipoic Acid Treatment Chronic Kidney Disease (TALAT)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- A statistically significant decrease in F2-isoprostanes, a specific oxidative stress marker
研究概览
简要总结
Oxidative stress and acute phase inflammation are now recognized to be highly prevalent in both the chronic kidney disease (CKD; pre-dialysis) and end stage renal disease (ESRD; on hemodialysis) populations, and several lines of evidence point to their contribution in the development of atherosclerosis. Biomarkers of the inflammatory state such as C-reactive protein (CRP) and interleukin-6 are robust predictors of cardiovascular events and death in these two populations. The uremic state is characterized by retention of oxidized solutes including reactive aldehyde groups and oxidized thiol groups. It has recently been demonstrated that initiation of maintenance hemodialysis does not improve biomarkers of oxidative stress or inflammation, suggesting that dialysis alone is inadequate to control the atherosclerotic uremic metabolic state. In this study we hypothesize that administration of antioxidant therapy will decrease biomarkers of acute phase inflammation and oxidative stress in patients with Stage III and IV CKD.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
干预措施: Alpha, gamma, beta, and delta (mixed) tocopherols (Drug)
1
干预措施: alpha lipoic acid (Drug)
2
干预措施: placebo (Drug)
结局指标
主要结局
A statistically significant decrease in F2-isoprostanes, a specific oxidative stress marker
时间窗: 4 months
次要结局
- A significant change in biomarkers of acute inflammation and oxidative stress from serum(4 months)
- A significant change in brachial artery vasodilatation measured by brachial impedence plethysmography(4 months)
