Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults With ADPKD
Primary Purpose
Polycystic Kidney, Autosomal Dominant
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Curcumin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Kidney, Autosomal Dominant
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
Sites / Locations
- University of Colorado Anschutz Medical Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Curcumin
Placebo
Arm Description
25/mg/kg per day for 1 year.
Equivalent placebo for 1 year.
Outcomes
Primary Outcome Measures
Percent Change in Brachial Artery Flow-mediated Dilation (FMD-BA)
co-primary endpoint
Change in Aortic Pulse-wave Velocity (aPWV) (cm/Sec)
co-primary endpoint
Secondary Outcome Measures
Change in Urinary 8-iso-prostaglandin F2α (8-isoprostane)
Urine marker of oxidative stress. Values are normalized to urinary creatinine.
Change in C-reactive Protein
Circulating marker of inflammation
Change in Interleukin-6
Circulating marker of inflammation
Percent Change in Oxidative Stress-associated Suppression of Endothelium-dependent Dilation (EDD)
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
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.
Full Information
NCT ID
NCT02494141
First Posted
June 25, 2015
Last Updated
February 8, 2022
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT02494141
Brief Title
Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults With ADPKD
Official Title
Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults With ADPKD
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 12, 2015 (Actual)
Primary Completion Date
February 1, 2021 (Actual)
Study Completion Date
February 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Kidney, Autosomal Dominant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Curcumin
Arm Type
Experimental
Arm Description
25/mg/kg per day for 1 year.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Equivalent placebo for 1 year.
Intervention Type
Drug
Intervention Name(s)
Curcumin
Other Intervention Name(s)
Longvida
Intervention Description
Dietary Supplement
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Percent Change in Brachial Artery Flow-mediated Dilation (FMD-BA)
Description
co-primary endpoint
Time Frame
Baseline, Month 12
Title
Change in Aortic Pulse-wave Velocity (aPWV) (cm/Sec)
Description
co-primary endpoint
Time Frame
Baseline, Month 12
Secondary Outcome Measure Information:
Title
Change in Urinary 8-iso-prostaglandin F2α (8-isoprostane)
Description
Urine marker of oxidative stress. Values are normalized to urinary creatinine.
Time Frame
Baseline, Month 12
Title
Change in C-reactive Protein
Description
Circulating marker of inflammation
Time Frame
Baseline, Month 12
Title
Change in Interleukin-6
Description
Circulating marker of inflammation
Time Frame
Baseline, Month 12
Title
Percent Change in Oxidative Stress-associated Suppression of Endothelium-dependent Dilation (EDD)
Description
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.
Time Frame
Baseline, Month 12
Title
Change in Oxidative Stress-Associated Suppression of Large Elastic Artery Stiffness
Description
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.
Time Frame
Baseline, Month 12
Other Pre-specified Outcome Measures:
Title
Change in Alanine Transaminase (ALT )
Description
Liver enzymes will be monitored for safety.
Time Frame
month 1, 6, and 12
Title
Change in Aspartate Aminotransferase (AST)
Description
Liver enzymes will be monitored for safety.
Time Frame
month 1, 6, and 12
Title
Change in Height-corrected Total Kidney Volume
Description
Total kidney volume will be measured by MRI
Time Frame
Baseline, Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristen L Nowak, Ph.D.
Organizational Affiliation
University of Colorado - Anschutz Medical Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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).
Citations:
PubMed Identifier
34907021
Citation
Nowak KL, Farmer-Bailey H, Wang W, You Z, Steele C, Cadnapaphornchai MA, Klawitter J, Patel N, George D, Jovanovich A, Soranno DE, Gitomer B, Chonchol M. Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults with ADPKD: A Randomized Controlled Trial. Clin J Am Soc Nephrol. 2022 Feb;17(2):240-250. doi: 10.2215/CJN.08950621. Epub 2021 Dec 14. Erratum In: Clin J Am Soc Nephrol. 2022 Jun;17(6):877-878.
Results Reference
derived
Learn more about this trial
Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults With ADPKD
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