Provision of Antioxidant Therapy in Hemodialysis (PATH) Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 385
- 试验地点
- 1
- 主要终点
- F2-isoprostane (F2-iso)
研究概览
简要总结
Studies have shown that end stage renal disease (ESRD) patients have higher levels of blood markers which their body makes in response to increased stress and injury. An increase in these markers have been shown to be related to cardiovascular disease and death in ESRD patients. This study will examine whether antioxidant therapy (Vitamin E and alpha lipoic acid) may decrease these markers.
详细描述
Oxidative stress and acute phase inflammation are now recognized to be highly prevalent in the hemodialysis population, and several lines of evidence point to their contribution in atherosclerosis development. Biomarkers of the inflammatory state such as C-reactive protein (CRP) and interleukin-6 are robust predictors of cardiovascular events and mortality in the dialysis population. 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 while improving the erythropoietic response in hemodialysis patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with end-stage renal disease receiving thrice weekly hemodialysis
- •Age > 18 years
- •Life expectancy greater than one year
- •Ability to understand and provide informed consent for participation in the study
排除标准
- •AIDS (HIV seropositivity is not an exclusion criteria)
- •Active malignancy excluding basal cell carcinoma of the skin
- •Gastrointestinal dysfunction requiring parenteral nutrition
- •History of functional kidney transplant < 6 months prior to study entry
- •Anticipated live donor kidney transplant over study duration
- •History of poor adherence to hemodialysis or medical regimen
- •Prisoners, patients with significant mental illness, pregnant women, and other vulnerable populations
- •Patients taking vitamin E supplements > 60 IU/day, vitamin C > 500 mg/day over the past 30 days
- •Patients taking anti-inflammatory medication except aspirin < 325 mg/day over the past 30 days
- •Patients using a temporary catheter for dialysis access
- •More than two hospitalizations within the last 90 days or one hospitalization within the last 30 days
研究组 & 干预措施
ALA and Vitamin E
600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of alpha, gamma, beta and delta (mixed) tocopherols (Vitamin E) taken orally on a daily basis for 6 months
干预措施: Alpha, gamma, beta, and delta (mixed) tocopherols (Drug)
ALA and Vitamin E
600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of alpha, gamma, beta and delta (mixed) tocopherols (Vitamin E) taken orally on a daily basis for 6 months
干预措施: Alpha lipoic acid (Drug)
Placebo
placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months
干预措施: Placebo (Drug)
结局指标
主要结局
F2-isoprostane (F2-iso)
时间窗: month 6
F2-iso is a sensitive laboratory assay for serum levels of F2-isoprostane, which is a biomarker of oxidative stress.
次要结局
- Interleukin-6 (IL-6)(month 6)
研究者
Alp Ikizler
Professor
Vanderbilt University