Phase 4
N=68
Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults With ADPKD
Polycystic Kidney, Autosomal Dominant
Bottom Line
View on ClinicalTrials.gov: NCT02494141 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: Percent Change in Brachial Artery Flow-mediated Dilation (FMD-BA) — 1.14; 0.3 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Curcumin (Drug); Placebo (Other)
- Age
- Pediatric, Adult · 6+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Brachial Artery Flow-mediated Dilation (FMD-BA) |
1.14; 0.3 | — |
| PRIMARY Change in Aortic Pulse-wave Velocity (aPWV) (cm/Sec) |
0.6; 6.5 | — |
| SECONDARY Change in Urinary 8-iso-prostaglandin F2α (8-isoprostane) |
0.00; 0.27 | — |
| SECONDARY Change in C-reactive Protein |
0.21; 0.17 | — |
| SECONDARY Change in Interleukin-6 |
2.24; 2.33 | — |
| SECONDARY Percent Change in Oxidative Stress-associated Suppression of Endothelium-dependent Dilation (EDD) |
3.0; 1.7; 1.1; 1.4 | — |
| SECONDARY Change in Oxidative Stress-Associated Suppression of Large Elastic Artery Stiffness |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02494141). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.