跳至主要内容
临床试验/NCT00308971
NCT00308971已完成2 期

Tocopherols and Alpha Lipoic Acid Treatment Chronic Kidney Disease (TALAT)

Vanderbilt University2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2006年3月最近更新:
适应症
干预措施
相关药物

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

1

Active Comparator

干预措施: Alpha, gamma, beta, and delta (mixed) tocopherols (Drug)

1

Active Comparator

干预措施: alpha lipoic acid (Drug)

2

Placebo Comparator

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)

研究者

申办方类型
Other

研究点 (2)

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