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
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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UNKNOWN
PHASE3
30 participants
INTERVENTIONAL
2022-12-01
2023-02-01
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Trial group
Children on regular hemodialysis whose weight 30 kg or above
Curcumin capsules 1 gm
Dietary supplement
Placebo group
Children on regular hemodialysis whose weight 30 kg or above
Placebo capsule
placebo corn starch
Interventions
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Curcumin capsules 1 gm
Dietary supplement
Placebo capsule
placebo corn starch
Eligibility Criteria
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Inclusion Criteria
* Undergoing regular hemodialysis for at least 6 months.
Exclusion Criteria
* 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.
10 Years
18 Years
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Iman Mohamed Naguib Alagamy
Assistant lecturer at Misr university for science and technology
Locations
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Iman Mohamed Naguib Alagamy
Cairo, , Egypt
Countries
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Central Contacts
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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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