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

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ClinicalTrials.gov Identifier: NCT02494141
Recruitment Status : Recruiting
First Posted : July 10, 2015
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE June 25, 2015
First Posted Date  ICMJE July 10, 2015
Last Update Posted Date May 20, 2019
Actual Study Start Date  ICMJE November 12, 2015
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2016)
  • Change in Brachial artery flow-mediated dilation (FMD-BA) (% change) [ 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
Original Primary Outcome Measures  ICMJE
 (submitted: July 7, 2015)
  • Brachial artery flow-mediated dilation (FMD-BA) (% change) [ Time Frame: Month 12 ]
    co-primary endpoint
  • Aortic pulse-wave velocity (aPWV) (cm/sec) [ Time Frame: Month 12 ]
    co-primary endpoint
Change History Complete list of historical versions of study NCT02494141 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2016)
  • Change in Urinary 8-iso-prostaglandin F2α (8-isoprostane) [ Time Frame: Baseline, Month 12 ]
    Urine marker of oxidative stress
  • Change in 8-hydroxy 2 deoxyguanosine (8-OHdG) [ Time Frame: Baseline, Month 12 ]
    Urine marker of oxidative stress
  • Change in C-reactive protein [ Time Frame: Baseline, Month 12 ]
    Circulating marker of inflammation
  • Change in Interleukin-6 [ Time Frame: Month 12 ]
    Circulating marker of inflammation
  • 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.
  • 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 Height-corrected total kidney volume [ Time Frame: Baseline, Month 12 ]
    Total kidney volume will be measured by MRI
Original Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2015)
  • Urinary 8-iso-prostaglandin F2α (8-isoprostane) [ Time Frame: Month 12 ]
    Urine marker of oxidative stress
  • 8-hydroxy 2 deoxyguanosine (8-OHdG) [ Time Frame: Month 12 ]
    Urine marker of oxidative stress
  • C-reactive protein [ Time Frame: Month 12 ]
    Circulating marker of inflammation
  • Interleukin-6 [ Time Frame: Month 12 ]
    Circulating marker of inflammation
  • Oxidative Stress-Associated Suppression of endothelium-dependent dilation (EDD) [ Time Frame: 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.
  • Oxidative Stress-Associated Suppression of Large Elastic Artery Stiffness [ Time Frame: 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.
  • Height-corrected total kidney volume [ Time Frame: Month 12 ]
    Total kidney volume will be measured by MRI
Current Other Pre-specified Outcome Measures
 (submitted: January 6, 2016)
  • Change in Plasma curcumin level [ Time Frame: Baseline, Month 12 ]
    Circulating levels of curcumin will be measured to verify delivery
  • 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.
Original Other Pre-specified Outcome Measures
 (submitted: July 7, 2015)
  • Plasma curcumin level [ Time Frame: Month 12 ]
    Circulating levels of curcumin will be measured to verify delivery
  • Alanine transaminase (ALT ) [ Time Frame: month 1, 6, and 12 ]
    Liver enzymes will be monitored for safety.
  • Aspartate aminotransferase (AST) [ Time Frame: month 1, 6, and 12 ]
    Liver enzymes will be monitored for safety.
 
Descriptive Information
Brief Title  ICMJE Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults With ADPKD
Official Title  ICMJE Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults With ADPKD
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Polycystic Kidney, Autosomal Dominant
Intervention  ICMJE
  • Drug: Curcumin
    Dietary Supplement
    Other Name: Longvida
  • Other: Placebo
Study Arms  ICMJE
  • Experimental: Curcumin
    25/mg/kg per day for 1 year.
    Intervention: Drug: Curcumin
  • Placebo Comparator: Placebo
    Equivalent placebo for 1 year.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 7, 2015)
68
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kristen L Nowak, Ph.D. 3037247790 Kristen.Nowak@ucdenver.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02494141
Other Study ID Numbers  ICMJE 15-0902
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kristen L Nowak, Ph.D. University of Colorado - Anschutz Medical Campus
PRS Account University of Colorado, Denver
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP