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

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 4

Conditions: Polycystic Kidney, Autosomal Dominant

Treatments: Drug: Curcumin; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02494141

15-0902

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 6 to 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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68 participants in 2 patient groups, including a placebo group

Curcumin

Experimental group

Description:

25/mg/kg per day for 1 year.

Treatment:

Drug: Curcumin

Placebo

Placebo Comparator group

Description:

Equivalent placebo for 1 year.

Treatment:

Other: Placebo