University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
NCT Number: NCT02494141
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.
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Notify Me6 year–25 year
All sexes
Interventional
Phase 4
Aurora, Colorado, 80045, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dietary Supplement
Other names: Longvida
Time frame: Baseline, Month 12
co-primary endpoint
Time frame: Baseline, Month 12
co-primary endpoint
Time frame: Baseline, Month 12
Urine marker of oxidative stress. Values are normalized to urinary creatinine.
Time frame: Baseline, Month 12
Circulating marker of inflammation
Time frame: Baseline, Month 12
Circulating marker of inflammation
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.
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.
Time frame: month 1, 6, and 12
Liver enzymes will be monitored for safety.
Time frame: month 1, 6, and 12
Liver enzymes will be monitored for safety.
Time frame: Baseline, Month 12
Total kidney volume will be measured by MRI
University of Colorado, Denver
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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