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

NCT ID: NCT03223883

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2023-01-25

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.

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.

Conditions

Chronic Kidney Diseases; Cognitive Decline

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Curcumin

Patients will receive curcumin (Lonvida) 2000 mg PO once a day

Group Type: EXPERIMENTAL

Curcumin

Intervention Type: DRUG

Oral supplement for 12 months

Placebo

Patients will receive placebo pill identical in appearance and taste to the supplement

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Oral placebo for 12 months

Interventions

Curcumin

Oral supplement for 12 months

Intervention Type: DRUG

Placebo

Oral placebo for 12 months

Intervention Type: OTHER

Other Intervention Names

Longvida

Eligibility 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Boulder

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

Diana Jalal

OTHER

Sponsor Role: lead

Responsible Party

Diana Jalal

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Diana Jalal

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa

Iowa City, Iowa, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

201710769

Identifier Type: -

Identifier Source: org_study_id