Back to resultsEffects of Curcumin on Inflammation and Oxidative Stress in Pediatric Patients on Regular Hemodialysis: A Randomized, Double-Blind, Placebo-Controlled Pilot Study
Primary Purpose
Pediatric Patients Having Renal Failure and on Regular Hemodialysis
Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Curcumin capsules 1 gm
Placebo capsule
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Patients Having Renal Failure and on Regular Hemodialysis
Eligibility Criteria
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.
Sites / Locations
- Iman Mohamed Naguib AlagamyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Trial group
Placebo group
Arm Description
Children on regular hemodialysis whose weight 30 kg or above
Children on regular hemodialysis whose weight 30 kg or above
Outcomes
Primary Outcome Measures
inflammatory marker
high sensitivity C reactive protein (CRP) at baseline before supplementation and after 3 months of supplementation
Secondary Outcome Measures
Oxidative stress markers
Serum tumor necrotizing factor alpha (TNF alpha)and malondialdehyde (MDA)at baseline and after 3 months of supplementation
Full Information
NCT ID
NCT05627843
First Posted
November 2, 2022
Last Updated
November 23, 2022
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT05627843
Brief Title
Effects of Curcumin on Inflammation and Oxidative Stress in Pediatric Patients on Regular Hemodialysis: A Randomized, Double-Blind, Placebo-Controlled Pilot Study
Official Title
Effects of Curcumin on Inflammation and Oxidative Stress in Paediatric Patients on Regular Hemodialysis: A Randomized, Double-Blind, Placebo-Controlled Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Anticipated)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Patients Having Renal Failure and on Regular Hemodialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Trial group
Arm Type
Experimental
Arm Description
Children on regular hemodialysis whose weight 30 kg or above
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Children on regular hemodialysis whose weight 30 kg or above
Intervention Type
Dietary Supplement
Intervention Name(s)
Curcumin capsules 1 gm
Intervention Description
Dietary supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo capsule
Intervention Description
placebo corn starch
Primary Outcome Measure Information:
Title
inflammatory marker
Description
high sensitivity C reactive protein (CRP) at baseline before supplementation and after 3 months of supplementation
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Oxidative stress markers
Description
Serum tumor necrotizing factor alpha (TNF alpha)and malondialdehyde (MDA)at baseline and after 3 months of supplementation
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iman Alagamy, Master degree in pediatrics
Phone
01201724974
Email
Iman.agamy@live.com
Facility Information:
Facility Name
Iman Mohamed Naguib Alagamy
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iman Alagamy
12. IPD Sharing Statement
Learn more about this trial
Effects of Curcumin on Inflammation and Oxidative Stress in Pediatric Patients on Regular Hemodialysis: A Randomized, Double-Blind, Placebo-Controlled Pilot Study
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