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Curcumin and Vascular and Cognitive Function in Patients With Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT03223883
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : February 1, 2018
Sponsor:
Collaborators:
University of Colorado, Boulder
Stanford University
University of Colorado, Denver
Information provided by (Responsible Party):
Diana Jalal, University of Iowa

Brief Summary:
The proposed research is clinical study evaluating the therapeutic benefits of curcumin on vascular function in patients with chronic kidney disease (CKD). The study aims to establish that curcumin will improve endothelial function and reduce large artery stiffness by reducing oxidative stress and in conjunction with lowering markers of inflammation and oxidative stress. In addition, the study will evaluate the potential benefit of curcumin on cognitive function in patients with CKD.

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Cognitive Decline Drug: Curcumin Other: Placebo Phase 2

Detailed Description:

Patients with chronic kidney disease (CKD) 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 CKD and contribute to the high incidence of CVD in this patient population. In addition, patients with CKD suffer from high rates of cognitive decline for which we lack effective therapies. Thus, therapeutic interventions targeting inflammation, oxidative stress, vascular dysfunction, and cognitive impairment in CKD are a biomedical priority.

Curcumin is a natural polyphenol with anti-inflammatory and antioxidant characteristics. It is safe and widely-available. Preliminary data in old mice and healthy middle-aged (MA)/older adult humans indicate that curcumin administration improves endothelial dysfunction and large artery stiffness by reducing oxidative stress and inflammation. Additionally, 12 weeks of curcumin supplementation improves episodic memory in MA/older adults.

The primary goal of this R01 application is to extend previous findings in healthy MA/older adults to patients with CKD, a growing clinical population with extensive baseline vascular dysfunction and cognitive impairment who presently have few treatment options. The hypothesis is that curcumin improves vascular endothelial function and large elastic artery stiffness in MA/older adults with stage IIIb and IV CKD (estimated GFR 15-45 mL/min/1.73m2). The possible mechanisms by which curcumin improves vascular function will be evaluated as well as whether curcumin improves cognitive function in these patients.

Specific aim 1a will determine if 12 months of curcumin supplementation will improve brachial artery-flow mediated dilation (BA-FMD) (endothelial function) and aortic pulse wave velocity (aPWV) (arterial stiffness) compared to placebo (randomized placebo-controlled double-blind study). Specific aim 1b will evaluate whether the curcumin-induced improvements in BA-FMD and aPWV are mediated by reduced oxidative stress, and will evaluate the effects of curcumin on systemic and endothelial cell markers of inflammation and oxidative stress. Importantly, specific aim 2 will evaluate the effects of curcumin supplementation on cognitive function, an important complication of CKD, using the NIH Cognitive Toolbox Battery.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Double-Blind Placebo-Controlled Clinical Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Patient, providers, and the investigative team will all be blinded to the randomization.
Primary Purpose: Treatment
Official Title: Curcumin Supplementation for Improving Vascular and Cognitive Function in Chronic Kidney Disease
Actual Study Start Date : January 30, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Curcumin

Arm Intervention/treatment
Experimental: Curcumin
Patients will receive curcumin (Lonvida) 2000 mg PO once a day
Drug: Curcumin
Oral supplement for 12 months
Other Name: Longvida

Placebo Comparator: Placebo
Patients will receive placebo pill identical in appearance and taste to the supplement
Other: Placebo
Oral placebo for 12 months




Primary Outcome Measures :
  1. Vascular endothelial function [ Time Frame: 12 months ]
    Brachial artery flow-mediated dilation


Secondary Outcome Measures :
  1. Large artery stiffness [ Time Frame: 12 months ]
    Aortic pulse wave velocity

  2. Cognitive function [ Time Frame: 12 months ]
    NIH toolbox battery



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CKD stage IIIB and IV
  • BMI<35 kg/m2
  • Able to give informed consent

Exclusion Criteria:

  • Consuming a diet rich in curcumin or taking curcumin supplements in the past 12 months
  • Life expectancy <1 year
  • Pregnant, breastfeeding, or unwilling to use adequate birth control
  • Uncontrolled hypertension
  • Severe liver disease
  • Severe congestive heart failure
  • Hospitalization within the last 3 months
  • Active infection or antibiotic therapy
  • Immunosuppressive therapy within the last year

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): NCT03223883


Contacts
Contact: Diana Jalal 7204254154 diana-jalal@uiowa.edu

Locations
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Diana I Jalal, MD    319-356-4113    diana-jalal@uiowa.edu   
Contact: Debra O'Connell, BA    319-356-1693    debra-oconnell-moore@uiowa.edu   
Principal Investigator: Diana I Jalal, MD         
Sponsors and Collaborators
Diana Jalal
University of Colorado, Boulder
Stanford University
University of Colorado, Denver
Investigators
Principal Investigator: Diana Jalal University of Iowa

Responsible Party: Diana Jalal, Associate Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03223883     History of Changes
Other Study ID Numbers: 201710769
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Curcumin
Kidney Diseases
Renal Insufficiency, Chronic
Cognitive Dysfunction
Urologic Diseases
Renal Insufficiency
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
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