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

Polycystic Kidney, Autosomal Dominant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02494141
• Other study ID #: 15-0902
• Status: Completed
• Phase: Phase 4
• Start date: November 12, 2015
• Est. completion date: February 1, 2021

Study information

• Verified date: February 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Dominant

Intervention

Drug:
• Curcumin
Dietary Supplement

Other:
• Placebo

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Alanine Transaminase (ALT )	Liver enzymes will be monitored for safety.	month 1, 6, and 12
Other	Change in Aspartate Aminotransferase (AST)	Liver enzymes will be monitored for safety.	month 1, 6, and 12
Other	Change in Height-corrected Total Kidney Volume	Total kidney volume will be measured by MRI	Baseline, Month 12
Primary	Percent Change in Brachial Artery Flow-mediated Dilation (FMD-BA)	co-primary endpoint	Baseline, Month 12
Primary	Change in Aortic Pulse-wave Velocity (aPWV) (cm/Sec)	co-primary endpoint	Baseline, Month 12
Secondary	Change in Urinary 8-iso-prostaglandin F2a (8-isoprostane)	Urine marker of oxidative stress. Values are normalized to urinary creatinine.	Baseline, Month 12
Secondary	Change in C-reactive Protein	Circulating marker of inflammation	Baseline, Month 12
Secondary	Change in Interleukin-6	Circulating marker of inflammation	Baseline, Month 12
Secondary	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.	Baseline, Month 12
Secondary	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.	Baseline, Month 12