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临床试验/NCT03935958
NCT03935958进行中(未招募)不适用

A Pilot 12 Month, Randomized, Controlled Trial of Curcumin in Kidney Transplant Recipients

University of Illinois at Chicago2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2019年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
14
试验地点
2
主要终点
Inflammation and oxidative stress

研究概览

简要总结

The primary goal of this study is to investigate if curcumin is beneficial for kidney transplant recipients, a population with extensive baseline vascular dysfunction and cognitive impairment who have few treatment options. The possible mechanisms by which curcumin improves vascular function will be evaluated as well as whether curcumin improves cognitive function in these patients.

详细描述

Kidney transplant recipients are at increased risk of death from cardiovascular disease (CVD). Inflammation, oxidative stress and vascular dysfunction (impaired endothelial function and increased large elastic artery stiffness), are highly prevalent in kidney transplant recipients and contribute to the high incidence of CVD in this patient population. The most common cause of kidney transplant failure is interstitial fibrosis and tubular atrophy (IFTA). The incidence of IFTA is as high as 50% of kidney transplants at 1 year after transplantation. The pathophysiology of IFTA is not well understood. Possible mechanisms include chronic rejection or injury, inflammation, and drug toxicity. Kidney transplant recipients suffer from high rates of cognitive decline for which the investigators lack effective therapies. Thus, therapeutic interventions targeting inflammation, oxidative stress, vascular dysfunction, and cognitive impairment are a priority.

Curcumin may have positive effects in terms of cardiovascular and nephroprotection because of its antibacterial, antiviral, anti-inflammatory and anti-oxidative effects. The aim of this study is to elucidate the role of curcumin as a nutritional strategy to reduce cardiovascular risk factors as well as inflammation and oxidative stress in kidney transplant recipients. The study aims to examine if curcumin will improve endothelial function by reducing markers of inflammation and oxidative stress. In addition, the study will evaluate the potential benefit of curcumin on cognitive function in kidney transplant recipients.

Curcumin is a natural polyphenol with anti-inflammatory and antioxidant characteristics. Preliminary data indicate that curcumin administration improves endothelial dysfunction by reducing oxidative stress and inflammation and may improve cognitive function.

The primary goal of this study is to investigate if curcumin is beneficial for kidney transplant recipients, a population with extensive baseline vascular dysfunction and cognitive impairment who have few treatment options. The possible mechanisms by which curcumin improves vascular function will be evaluated as well as whether curcumin improves cognitive function in these patients.

Objectives:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

participants will not know if they are receiving curcumin or placebo

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The subject is a recipient of a living donor or deceased donor kidney only transplant
  • The subject is > 18 years of age

排除标准

  • The subject has had a multi-organ transplant
  • Subjects that were taking curcumin pre-transplant

研究组 & 干预措施

Curcumin Arm (Arm 1)

Experimental

20 subjects will be randomized (1:1) to this arm and receive curcumin for a year. In addition, subjects will have four study visits at Day 0, and 3, 6 and 12 months post-transplant. These study visits also include blood samples and questionnaires.

干预措施: Curcumin (Dietary Supplement)

Placebo Arm (Arm 2)

Placebo Comparator

20 subjects will be randomized (1:1) to this arm and receive placebo for a year. In addition, subjects will have four study visits at Day 0, and 3, 6 and 12 months post-transplant. These study visits also include blood samples and questionnaires.

干预措施: Placebo (Other)

结局指标

主要结局

Inflammation and oxidative stress

时间窗: 12 months

Markers of inflammation and oxidative stress at 0,3,6, \& 12 months

Graft Outcomes

时间窗: 12 months

Change in GFR at 3, 6 and 12 months

Cognitive function & Pain

时间窗: 12 months

Change in Neuro-QOL Item Bank v2.0 at 0, 3, 6, and 12 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pierpaolo Di Cocco

Assistant Professor in Surgery

University of Illinois at Chicago

研究点 (2)

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