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

NCT ID: NCT05627843

Last Updated: 2022-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2023-02-01

Brief Summary

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* 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

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Conditions

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Pediatric Patients Having Renal Failure and on Regular Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Trial group

Children on regular hemodialysis whose weight 30 kg or above

Group Type EXPERIMENTAL

Curcumin capsules 1 gm

Intervention Type DIETARY_SUPPLEMENT

Dietary supplement

Placebo group

Children on regular hemodialysis whose weight 30 kg or above

Group Type PLACEBO_COMPARATOR

Placebo capsule

Intervention Type DIETARY_SUPPLEMENT

placebo corn starch

Interventions

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Curcumin capsules 1 gm

Dietary supplement

Intervention Type DIETARY_SUPPLEMENT

Placebo capsule

placebo corn starch

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Iman Mohamed Naguib Alagamy

Assistant lecturer at Misr university for science and technology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Iman Mohamed Naguib Alagamy

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Iman Alagamy, Master degree in pediatrics

Role: CONTACT

01201724974

Facility Contacts

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Iman Alagamy

Role: primary

Other Identifiers

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MD 181 / 2021

Identifier Type: -

Identifier Source: org_study_id

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