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
• Interventions: Dietary Supplement: Curcumin capsules 1 gm; Dietary Supplement: Placebo capsule

• 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

Arm && Interventions

Group	Intervention	Description
Trial group	Curcumin capsules 1 gm	Children on regular hemodialysis whose weight 30 kg or above
Placebo group	Placebo capsule	Children on regular hemodialysis whose weight 30 kg or above

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