Polycystic Kidney, Autosomal Dominant Clinical Trial
Official title:
Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults With ADPKD
Verified date | February 2022 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Anschutz Medical Campus | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver |
United States,
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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