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

NCT03223883 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 201710769
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases; Cognitive Decline

Outcome Measures

Primary Outcomes (1)

• Change in Vascular Endothelial Function at 12 Months

  Brachial artery flow-mediated dilation, changed in diameter in brachial artery in response to shear stress

  12 months

Secondary Outcomes (2)

• Large Artery Stiffness

  12 months

• Cognitive Function

  12 months

Study Arms (2)

Curcumin

EXPERIMENTAL

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

Drug: Curcumin

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Curcumin DRUG

Oral supplement for 12 months

Also known as: Longvida

Curcumin

Placebo OTHER

Oral placebo for 12 months

Placebo

Eligibility Criteria

• Age: 45 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Diana Jalal: lead
• University of Colorado, Boulder: collaborator
• Stanford University: collaborator
• University of Colorado, Denver: collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Cognitive Dysfunction

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Results Point of Contact

• Title: Dr. Diana Jalal
• Organization: University of Iowa Carver College of Medicine

diana-jalal@uiowa.edu

319-356-3500

Study Officials

• Diana Jalal

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patient, providers, and the investigative team will all be blinded to the randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized Double-Blind Placebo-Controlled Clinical Trial

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: July 21, 2017
• Study Start: June 1, 2018
• Primary Completion: January 25, 2023
• Study Completion: January 25, 2023
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)