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

November 23, 2022 updated by: Iman Mohamed Naguib Alagamy, Ain Shams University

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

  • 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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Iman Alagamy, Master degree in pediatrics
  • Phone Number: 01201724974
  • Email: Iman.agamy@live.com

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Iman Mohamed Naguib Alagamy
        • Contact:
          • Iman Alagamy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Trial group
Children on regular hemodialysis whose weight 30 kg or above
Dietary supplement: Curcumin capsules 1 gm
Dietary supplement
Placebo Comparator: Placebo group
Children on regular hemodialysis whose weight 30 kg or above
Dietary supplement: Placebo capsule
placebo corn starch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
inflammatory marker
Time Frame: 3 months
high sensitivity C reactive protein (CRP) at baseline before supplementation and after 3 months of supplementation
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxidative stress markers
Time Frame: 3 months
Serum tumor necrotizing factor alpha (TNF alpha)and malondialdehyde (MDA)at baseline and after 3 months of supplementation
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2022

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

November 2, 2022

First Submitted That Met QC Criteria

November 23, 2022

First Posted (Actual)

November 28, 2022

Study Record Updates

Last Update Posted (Actual)

November 28, 2022

Last Update Submitted That Met QC Criteria

November 23, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD 181 / 2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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