Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults With ADPKD
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ClinicalTrials.gov Identifier: NCT02494141 |
Recruitment Status :
Completed
First Posted : July 10, 2015
Results First Posted : March 3, 2022
Last Update Posted : March 3, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Polycystic Kidney, Autosomal Dominant | Drug: Curcumin Other: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 68 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults With ADPKD |
Actual Study Start Date : | November 12, 2015 |
Actual Primary Completion Date : | February 1, 2021 |
Actual Study Completion Date : | February 1, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Curcumin
25/mg/kg per day for 1 year.
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Drug: Curcumin
Dietary Supplement
Other Name: Longvida |
Placebo Comparator: Placebo
Equivalent placebo for 1 year.
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Other: Placebo |
- 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
- 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.
- Change in Alanine Transaminase (ALT ) [ Time Frame: month 1, 6, and 12 ]Liver enzymes will be monitored for safety.
- Change in Aspartate Aminotransferase (AST) [ Time Frame: month 1, 6, and 12 ]Liver enzymes will be monitored for safety.
- Change in Height-corrected Total Kidney Volume [ Time Frame: Baseline, Month 12 ]Total kidney volume will be measured by MRI

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Ages Eligible for Study: | 6 Years to 25 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02494141
United States, Colorado | |
University of Colorado Anschutz Medical Campus | |
Aurora, Colorado, United States, 80045 |
Principal Investigator: | Kristen L Nowak, Ph.D. | University of Colorado - Anschutz Medical Campus |
Documents provided by University of Colorado, Denver:
Responsible Party: | University of Colorado, Denver |
ClinicalTrials.gov Identifier: | NCT02494141 |
Other Study ID Numbers: |
15-0902 |
First Posted: | July 10, 2015 Key Record Dates |
Results First Posted: | March 3, 2022 |
Last Update Posted: | March 3, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Data obtained through this study may be provided to qualified researchers with academic interest in ADPKD. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. data use agreement) are prerequisites to the sharing of data with the requesting party. |
Supporting Materials: |
Study Protocol Informed Consent Form (ICF) |
Time Frame: | Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis. |
Access Criteria: | Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). |
Curcumin Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Kidney Diseases, Cystic Kidney Diseases Urologic Diseases Abnormalities, Multiple Congenital Abnormalities Ciliopathies Genetic Diseases, Inborn Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |