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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 1, 2021

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.

Interventions

  • Drug: Curcumin
    • Dietary Supplement
  • Other: Placebo

Arms, Groups and Cohorts

  • Experimental: Curcumin
    • 25/mg/kg per day for 1 year.
  • Placebo Comparator: Placebo
    • Equivalent placebo for 1 year.

Clinical Trial Outcome Measures

Primary Measures

  • Percent Change in Brachial Artery Flow-mediated Dilation (FMD-BA)
    • Time Frame: Baseline, Month 12
    • co-primary endpoint
  • Change in Aortic Pulse-wave Velocity (aPWV) (cm/Sec)
    • Time Frame: Baseline, Month 12
    • co-primary endpoint

Secondary Measures

  • Change in Urinary 8-iso-prostaglandin F2α (8-isoprostane)
    • Time Frame: Baseline, Month 12
    • Urine marker of oxidative stress. Values are normalized to urinary creatinine.
  • Change in C-reactive Protein
    • Time Frame: Baseline, Month 12
    • Circulating marker of inflammation
  • Change in Interleukin-6
    • Time Frame: Baseline, Month 12
    • Circulating marker of inflammation
  • Percent Change in Oxidative Stress-associated Suppression of Endothelium-dependent Dilation (EDD)
    • Time Frame: Baseline, Month 12
    • The influence of oxidative stress on FMD-BA will be determined by infusing a supraphysiological dose of ascorbic acid known to scavenge superoxide or isovolumic saline. The outcome measure describes the value of the percent change with ascorbic acid compared to saline observed at baseline and the value of the percent change with ascorbic acid compared to saline at the month 12 timepoint.
  • Change in Oxidative Stress-Associated Suppression of Large Elastic Artery Stiffness
    • Time Frame: Baseline, Month 12
    • The influence of oxidative stress on aPWV will be determined by infusing a supraphysiological dose of ascorbic acid known to scavenge superoxide or isovolumic saline.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: 25 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Colorado, Denver
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kristen L Nowak, Ph.D., Principal Investigator, University of Colorado – Anschutz Medical Campus

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