A Pilot 12 Month, Randomized, Controlled Trial of Curcumin in Kidney Transplant Recipients
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
- 否
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)
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)
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
Pierpaolo Di Cocco
Assistant Professor in Surgery
University of Illinois at Chicago
