Effects of Curcumin on Inflammation and Oxidative Stress in Pediatric Patients on Regular Hemodialysis: A Randomized, Double-Blind, Placebo-Controlled Pilot Study
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2022
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 2022
CompletedFirst Posted
Study publicly available on registry
November 28, 2022
CompletedStudy Start
First participant enrolled
December 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2023
CompletedNovember 28, 2022
November 1, 2022
2 months
November 2, 2022
November 23, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
inflammatory marker
high sensitivity C reactive protein (CRP) at baseline before supplementation and after 3 months of supplementation
3 months
Secondary Outcomes (1)
Oxidative stress markers
3 months
Study Arms (2)
Trial group
EXPERIMENTALChildren on regular hemodialysis whose weight 30 kg or above
Placebo group
PLACEBO COMPARATORChildren on regular hemodialysis whose weight 30 kg or above
Interventions
Eligibility Criteria
You may qualify if:
- Male or female pediatric patients with weight of at least 30 kilograms.
- Undergoing regular hemodialysis for at least 6 months.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Iman Mohamed Naguib Alagamy
Cairo, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant lecturer at Misr university for science and technology
Study Record Dates
First Submitted
November 2, 2022
First Posted
November 28, 2022
Study Start
December 1, 2022
Primary Completion
February 1, 2023
Study Completion
February 1, 2023
Last Updated
November 28, 2022
Record last verified: 2022-11