Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults With ADPKD

NCT ID: NCT02494141

Last Updated: 2022-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-12
• Study Completion Date: 2021-02-01

Brief Summary

The proposed research will determine the effectiveness of curcumin for improving the health and function of arteries in children and young adults with autosomal dominant polycystic kidney disease (ADPKD). The study also will provide insight into how curcumin improves artery health by determining the physiological mechanisms (biological reasons) involved and offer exploratory evidence if curcumin can slow kidney growth. This will be done by comparing these measurements in children and young adults who are randomized to receive either curcumin or placebo for 1 year.

Detailed Description

Although often considered to be a disease of adults, complications of autosomal dominant polycystic kidney disease (ADPKD) begin in childhood. While ADPKD causes the continued growth of multiple kidney cysts that ultimately result in loss of kidney function, the leading cause of death among patients with ADPKD is cardiovascular disease. Treatment options to prevent cardiovascular disease in adults with ADPKD are limited, thus childhood may be an important time to reduce risk. Curcumin is a safe, naturally occurring substance found in the Indian spice tumeric, which is in curry powder. The proposed research will determine the effectiveness of curcumin for improving the health and function of arteries in children and young adults with ADPKD. The study also will provide insight into how curcumin improves artery health by determining the physiological mechanisms (biological reasons) involved and offer exploratory evidence if curcumin can slow kidney growth. This will be done by comparing these measurements in children and young adults who are randomized to receive either curcumin or placebo for 1 year.

Conditions

Polycystic Kidney, Autosomal Dominant

Study Design

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

Study Groups

Curcumin

25/mg/kg per day for 1 year.

Group Type: EXPERIMENTAL

Curcumin

Intervention Type: DRUG

Dietary Supplement

Placebo

Equivalent placebo for 1 year.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Interventions

Curcumin

Dietary Supplement

Intervention Type: DRUG

Placebo

Intervention Type: OTHER

Other Intervention Names

Longvida

Eligibility Criteria

Inclusion Criteria

• ADPKD diagnosis
• Normal renal function (estimated glomerular filtration rate >80 mL/min/1.73m^2)
• Ability to provide informed consent

Exclusion Criteria

• Currently taking a curcumin supplement
• Current smoking or history of smoking in the past 12 months
• Marijuana use within 2 weeks prior to FMDBA and aPWV testing
• Antioxidantand/or omega-3 fatty acid use within the past 4 weeks prior to FMDBA and aPWV testing and for the duration of the study
• Alcohol dependence and abuse
• History of hospitalization within the last 3 months
• Active infection or antibiotic therapy
• Pregnancy, lactation, or unwillingness to use adequate birth control
• Body-mass index >95th percentile in ages 6-17 or >40 kg/m2 in ages 18-25
• Inability to cooperate with/clinical contraindication for MRI including severe claustrophobia, implants, devices, or non-removable body piercings

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristen L Nowak, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Countries

United States

References

Nowak KL, Farmer-Bailey H, Wang W, You Z, Steele C, Cadnapaphornchai MA, Klawitter J, Patel N, George D, Jovanovich A, Soranno DE, Gitomer B, Chonchol M. Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults with ADPKD: A Randomized Controlled Trial. Clin J Am Soc Nephrol. 2022 Feb;17(2):240-250. doi: 10.2215/CJN.08950621. Epub 2021 Dec 14.

Reference Type: DERIVED

PMID: 34907021 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

15-0902

Identifier Type: -

Identifier Source: org_study_id