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Trial record 64 of 167 for:    curcumin

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
Sponsor:
Collaborator:
Verdure Sciences
Information provided by (Responsible Party):
Patricia West-Thielke, University of Illinois at Chicago

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Disorder Related to Renal Transplantation Dietary Supplement: Curcumin Other: Placebo Not Applicable

Detailed Description:

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:

  1. Evaluate the effects of curcumin on kidney transplant graft function
  2. Evaluate the effects of curcumin supplementation on cognitive function.
  3. Evaluate the effects of curcumin on diabetes and cardiovascular outcomes
  4. Evaluate the effects of curcumin on systemic and endothelial cell markers of inflammation and oxidative stress.

Methods:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

20 participants in supplement (receiving curcumin) group 20 participants in control (receiving placebo) group

randomization 1:1

Masking: Single (Participant)
Masking Description: participants will not know if they are receiving curcumin or placebo
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arm Intervention/treatment
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.
Other: Placebo
Patients will receive placebo capsule identical in appearance and taste to the supplement, for 12 months
Other Name: Longvida




Primary Outcome Measures :
  1. Graft Outcomes [ Time Frame: 12 months ]
    Change in GFR at 3, 6 and 12 months

  2. Diabetes Outcomes [ Time Frame: 12 months ]
    Change in A1C at 0, 3 6, and 12 months

  3. Cardiovascular Outcomes [ Time Frame: 12 months ]
    Change in total cholesterol at 0, 3, 6 and 12 months

  4. Cognitive function [ Time Frame: 12 months ]
    Change in Neuro-QOL Item Bank v2.0 at 0, 3, 6, and 12 months

  5. Graft Outcomes [ Time Frame: 12 months ]
    Difference in biopsy scores at 3, 6 and 12 months

  6. Cognitive function [ Time Frame: 12 months ]
    Change in SF-36 at 0, 3, 6, and 12 months

  7. Cardiovascular Outcomes [ Time Frame: 12 months ]
    Change in total cholesterol and LDL-C at 0, 3, 6 and 12 months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. The subject has had a multi-organ transplant
  2. Subjects that were taking curcumin pre-transplant
  3. Subjects that have a BMI > 35 kg/m2

Information from the National Library of Medicine

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


Contacts
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Contact: Patricia West-Thielke, PharmD 312-996-5695 pwest@uic.edu
Contact: Natalie Isho, MPH 312-996-4706 nisho@uic.edu

Locations
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United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Kelly Bruno, BS    312-996-3806    kbruno@uic.edu   
Contact: Doris Cikopana, BA    312.413.7370    dcikop2@uic.edu   
Sponsors and Collaborators
University of Illinois at Chicago
Verdure Sciences
Investigators
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Principal Investigator: Patricia West-Thielke, PharmD UI Health

Publications:
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Responsible Party: Patricia West-Thielke, Director of Transplant Research, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT03935958     History of Changes
Other Study ID Numbers: 2019-0321
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Patricia West-Thielke, University of Illinois at Chicago:
kidney transplantation
inflammation
vascular dysfunction
cognitive impairment
oxidative stress
graft function
Additional relevant MeSH terms:
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Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action