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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05627843
Enrollment
30
Registered
2022-11-28
Start date
2022-12-01
Completion date
2023-02-01
Last updated
2022-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Patients Having Renal Failure and on Regular Hemodialysis

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.

Interventions

DIETARY_SUPPLEMENTCurcumin capsules 1 gm

Dietary supplement

DIETARY_SUPPLEMENTPlacebo capsule

placebo corn starch

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
inflammatory marker3 monthshigh sensitivity C reactive protein (CRP) at baseline before supplementation and after 3 months of supplementation

Secondary

MeasureTime frameDescription
Oxidative stress markers3 monthsSerum tumor necrotizing factor alpha (TNF alpha)and malondialdehyde (MDA)at baseline and after 3 months of supplementation

Countries

Egypt

Contacts

Primary ContactIman Alagamy, Master degree in pediatrics
Iman.agamy@live.com01201724974

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026