Clinical trial NCT02494141: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polycystic Kidney, Autosomal Dominant
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2015-07-10
Enrollment: 68
Sex: ALL
Minimum age (years): 6
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percent Change in Brachial Artery Flow-mediated Dilation (FMD-BA)
timeFrame: Baseline, Month 12
measure: Change in Aortic Pulse-wave Velocity (aPWV) (cm/Sec)
timeFrame: Baseline, Month 12
Secondary outcomes:
measure: Change in Urinary 8-iso-prostaglandin F2α (8-isoprostane)
timeFrame: Baseline, Month 12
measure: Change in C-reactive Protein
timeFrame: Baseline, Month 12
measure: Change in Interleukin-6
timeFrame: Baseline, Month 12
measure: Percent Change in Oxidative Stress-associated Suppression of Endothelium-dependent Dilation (EDD)
timeFrame: Baseline, Month 12
measure: Change in Oxidative Stress-Associated Suppression of Large Elastic Artery Stiffness
timeFrame: Baseline, Month 12
Other outcomes:
measure: Change in Alanine Transaminase (ALT )
timeFrame: month 1, 6, and 12
measure: Change in Aspartate Aminotransferase (AST)
timeFrame: month 1, 6, and 12
measure: Change in Height-corrected Total Kidney Volume
timeFrame: Baseline, Month 12
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Kristen L Nowak, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.