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

Phase 3

Recruiting

• Conditions: Pediatric Patients Having Renal Failure and on Regular Hemodialysis

• Registration Number: NCT05627843
• Lead Sponsor: Ain Shams University

Brief Summary

* 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-02
• Study First Submitted QC: 2022-11-23
• Last Update Submitted: 2022-11-23
• Study First Posted: 2022-11-28
• Last Update Posted: 2022-11-28
• Study Start: 2022-12-01
• Primary Completion: 2023-02
• Study Completion: 2023-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
inflammatory marker	3 months	high sensitivity C reactive protein (CRP) at baseline before supplementation and after 3 months of supplementation

Secondary Outcome Measures

Name	Time	Method
Oxidative stress markers	3 months	Serum tumor necrotizing factor alpha (TNF alpha)and malondialdehyde (MDA)at baseline and after 3 months of supplementation

Trial Locations

Locations (1)

Iman Mohamed Naguib Alagamy; 🇪🇬 Cairo, Egypt