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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02494141
Other study ID # 15-0902
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 12, 2015
Est. completion date February 1, 2021

Study information

Verified date February 2022
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date February 1, 2021
Est. primary completion date February 1, 2021
Accepts healthy volunteers No
Gender All
Age group 6 Years to 25 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Curcumin
Dietary Supplement
Other:
Placebo


Locations

Country Name City State
United States University of Colorado Anschutz Medical Campus Aurora Colorado

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in Alanine Transaminase (ALT ) Liver enzymes will be monitored for safety. month 1, 6, and 12
Other Change in Aspartate Aminotransferase (AST) Liver enzymes will be monitored for safety. month 1, 6, and 12
Other Change in Height-corrected Total Kidney Volume Total kidney volume will be measured by MRI Baseline, Month 12
Primary Percent Change in Brachial Artery Flow-mediated Dilation (FMD-BA) co-primary endpoint Baseline, Month 12
Primary Change in Aortic Pulse-wave Velocity (aPWV) (cm/Sec) co-primary endpoint Baseline, Month 12
Secondary Change in Urinary 8-iso-prostaglandin F2a (8-isoprostane) Urine marker of oxidative stress. Values are normalized to urinary creatinine. Baseline, Month 12
Secondary Change in C-reactive Protein Circulating marker of inflammation Baseline, Month 12
Secondary Change in Interleukin-6 Circulating marker of inflammation Baseline, Month 12
Secondary Percent Change in Oxidative Stress-associated Suppression of Endothelium-dependent Dilation (EDD) 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. Baseline, Month 12
Secondary Change in Oxidative Stress-Associated Suppression of Large Elastic Artery Stiffness 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. Baseline, Month 12
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