Curcumin in Kidney Transplant Recipients
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|ClinicalTrials.gov Identifier: NCT03935958|
Recruitment Status : Recruiting
First Posted : May 2, 2019
Last Update Posted : September 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Disorder Related to Renal Transplantation||Dietary Supplement: Curcumin Other: Placebo||Not Applicable|
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.
- Evaluate the effects of curcumin on kidney transplant graft function
- Evaluate the effects of curcumin supplementation on cognitive function.
- Evaluate the effects of curcumin on diabetes and cardiovascular outcomes
- Evaluate the effects of curcumin on systemic and endothelial cell markers of inflammation and oxidative stress.
Patients will be randomized 1:1 to receive either curcumin or placebo starting at the time of transplant or up to 2 weeks prior to transplant. Patients will be followed per standard of care for kidney transplant recipients. Additional blood (30mL) and urine samples will be drawn prior to transplant and at 3, 6 and 12 months post-transplant to be used for future analysis. There will be a total of 4 visits for this study. Additionally, two questionnaires will be distributed at each visit.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
20 participants in supplement (receiving curcumin) group 20 participants in control (receiving placebo) group
|Masking Description:||participants will not know if they are receiving curcumin or placebo|
|Official Title:||A Pilot 12 Month, Randomized, Controlled Trial of Curcumin in Kidney Transplant Recipients|
|Estimated Study Start Date :||October 2019|
|Estimated Primary Completion Date :||May 2022|
|Estimated Study Completion Date :||May 2023|
Experimental: 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 and urine samples and questionnaires.
Dietary Supplement: Curcumin
Patients will receive curcumin (Longvida) 2000 mg, once a day, for 12 months
Other Name: Longvida
Placebo Comparator: 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 and urine samples and questionnaires.
Patients will receive placebo capsule identical in appearance and taste to the supplement, for 12 months
Other Name: Longvida
- Graft Outcomes [ Time Frame: 12 months ]Change in GFR at 3, 6 and 12 months
- Diabetes Outcomes [ Time Frame: 12 months ]Change in A1C at 0, 3 6, and 12 months
- Cardiovascular Outcomes [ Time Frame: 12 months ]Change in total cholesterol at 0, 3, 6 and 12 months
- Cognitive function [ Time Frame: 12 months ]Change in Neuro-QOL Item Bank v2.0 at 0, 3, 6, and 12 months
- Graft Outcomes [ Time Frame: 12 months ]Difference in biopsy scores at 3, 6 and 12 months
- Cognitive function [ Time Frame: 12 months ]Change in SF-36 at 0, 3, 6, and 12 months
- Cardiovascular Outcomes [ Time Frame: 12 months ]Change in total cholesterol and LDL-C at 0, 3, 6 and 12 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03935958
|Contact: Patricia West-Thielke, PharmDfirstname.lastname@example.org|
|Contact: Natalie Isho, MPHemail@example.com|
|Principal Investigator:||Patricia West-Thielke, PharmD||UI Health|