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

February 8, 2022 updated by: University of Colorado, Denver
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 23 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Curcumin
25/mg/kg per day for 1 year.
Drug: Curcumin
Dietary Supplement
Other Names:
  • Longvida
Placebo Comparator: Placebo
Equivalent placebo for 1 year.
Other: Placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Month 12
Change in C-reactive Protein
Time Frame: Baseline, Month 12
Circulating marker of inflammation
Baseline, Month 12
Change in Interleukin-6
Time Frame: Baseline, Month 12
Circulating marker of inflammation
Baseline, Month 12
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.
Baseline, Month 12
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.
Baseline, Month 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Alanine Transaminase (ALT )
Time Frame: month 1, 6, and 12
Liver enzymes will be monitored for safety.
month 1, 6, and 12
Change in Aspartate Aminotransferase (AST)
Time Frame: month 1, 6, and 12
Liver enzymes will be monitored for safety.
month 1, 6, and 12
Change in Height-corrected Total Kidney Volume
Time Frame: Baseline, Month 12
Total kidney volume will be measured by MRI
Baseline, Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Kristen L Nowak, Ph.D., University of Colorado - Anschutz Medical Campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2015

Primary Completion (Actual)

February 1, 2021

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

June 25, 2015

First Submitted That Met QC Criteria

July 7, 2015

First Posted (Estimate)

July 10, 2015

Study Record Updates

Last Update Posted (Actual)

March 3, 2022

Last Update Submitted That Met QC Criteria

February 8, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-0902

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

IPD Sharing 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.

IPD Sharing 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).

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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