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

Ain Shams University30 enrolled

Overview

* 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pediatric Patients Having Renal Failure and on Regular Hemodialysis

Interventions

Eligibility

Sex: ALLMin age: 10 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

inflammatory marker

high sensitivity C reactive protein (CRP) at baseline before supplementation and after 3 months of supplementation

Time frame: 3 months

Secondary Outcomes

Oxidative stress markers

Serum tumor necrotizing factor alpha (TNF alpha)and malondialdehyde (MDA)at baseline and after 3 months of supplementation