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Trial record 1 of 3 for:    curcumin denver
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Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults With ADPKD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02494141
Recruitment Status : Completed
First Posted : July 10, 2015
Results First Posted : March 3, 2022
Last Update Posted : March 3, 2022
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Polycystic Kidney, Autosomal Dominant Drug: Curcumin Other: Placebo Phase 4

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 Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Curcumin
25/mg/kg per day for 1 year.
 Drug: Curcumin
Dietary Supplement
Other Name: Longvida
Placebo Comparator: Placebo
Equivalent placebo for 1 year.
 Other: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Percent Change in Brachial Artery Flow-mediated Dilation (FMD-BA) [ Time Frame: Baseline, Month 12 ]
    co-primary endpoint

  2. Change in Aortic Pulse-wave Velocity (aPWV) (cm/Sec) [ Time Frame: Baseline, Month 12 ]
    co-primary endpoint


Secondary Outcome Measures :
  1. 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.

  2. Change in C-reactive Protein [ Time Frame: Baseline, Month 12 ]
    Circulating marker of inflammation

  3. Change in Interleukin-6 [ Time Frame: Baseline, Month 12 ]
    Circulating marker of inflammation

  4. 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.

  5. 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.


Other Outcome Measures:
  1. Change in Alanine Transaminase (ALT ) [ Time Frame: month 1, 6, and 12 ]
    Liver enzymes will be monitored for safety.

  2. Change in Aspartate Aminotransferase (AST) [ Time Frame: month 1, 6, and 12 ]
    Liver enzymes will be monitored for safety.

  3. Change in Height-corrected Total Kidney Volume [ Time Frame: Baseline, Month 12 ]
    Total kidney volume will be measured by MRI


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Colorado
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Kristen L Nowak, Ph.D. University of Colorado - Anschutz Medical Campus
  Study Documents (Full-Text)

Documents provided by University of Colorado, Denver:
Study Protocol and Statistical Analysis Plan  [PDF] March 12, 2020
Informed Consent Form  [PDF] December 11, 2020

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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).
Additional relevant MeSH terms:
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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