Effects of Curcumin on Inflammation and Oxidative Stress in Pediatric Patients on Regular Hemodialysis: A Randomized, Double-Blind, Placebo-Controlled Pilot Study

Ain Shams University

Status and phase: Enrolling; Phase 3

Conditions: Pediatric Patients Having Renal Failure and on Regular Hemodialysis

Treatments: Dietary Supplement: Curcumin capsules 1 gm; Dietary Supplement: Placebo capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT05627843

MD 181 / 2021

Details and patient eligibility

About

• The study will be a randomised, double blinded, placebo controlled design.
• It will include 2 groups : trial group and placebo group
• Patients in both groups are children on regular hemodialysis
• The patients in the trial group will receive Curcumin capsule 1 gm for 3 months , and the placebo group will receive a placebo capsule for 3 months
• All patients will be evaluated clinically, and laboratory at baseline, at 3 months after end of supplementation.

Enrollment: 30 estimated patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female pediatric patients with weight of at least 30 kilograms.
• Undergoing regular hemodialysis for at least 6 months.

Exclusion criteria

• Bleeding disorders.
• Chronic liver disease.
• Diabetes mellitus.
• Autoimmune diseases.
• Receiving drugs that are contraindicated, or have major interactions with curcumin, and can't be discontinued or replaced.
• Receiving corticosteroids, or immune-suppressants.
• Patients taking any antioxidant supplements including vitamin E, ascorbic acid, omega -3 fatty acid, or L-carnitine within 3 months prior to enrollment in our study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Trial group

Experimental group

Description:

Children on regular hemodialysis whose weight 30 kg or above

Treatment:

Dietary Supplement: Curcumin capsules 1 gm

Placebo group

Placebo Comparator group

Description:

Children on regular hemodialysis whose weight 30 kg or above

Treatment:

Dietary Supplement: Placebo capsule