Efficacy and Safety of Coenzyme Q10 in Pediatric Hemodialysis Patients

NCT ID: NCT05170893

Last Updated: 2023-07-19

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

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-17

Study Completion Date

2022-07-26

Brief Summary

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All chronic kidney disease patients, whether on regular hemodialysis or not, are at high risk of cardiovascular diseases. This is mainly due to increased oxidative stress, reduced antioxidants and generalized inflammation. Coenzyme Q10 is a vitamin-like antioxidant synthesized in almost all body cells, and it is also available in many dietary sources. It was observed that chronic kidney disease patients have low plasma levels of Coenzyme Q10. Clinical benefits of Coenzyme Q10 supplementation have been documented for various cardiovascular and neurodegenerative disorders. The investigators believe that Coenzyme Q10 supplementation may have potential benefits in pediatric patients receiving hemodialysis; mainly due to its antioxidant activity and anti-inflammatory effects.

Detailed Description

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Conditions

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Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Intervention group

Oral Coenzyme Q10 capsules daily for 12 weeks.

Group Type EXPERIMENTAL

Coenzyme Q10

Intervention Type DIETARY_SUPPLEMENT

Oral capsules

Control group

Oral capsules similar to the intervention daily for 12 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Oral capsules

Interventions

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Coenzyme Q10

Oral capsules

Intervention Type DIETARY_SUPPLEMENT

Placebo

Oral capsules

Intervention Type OTHER

Other Intervention Names

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ubiquinone, ubidecarenone, ubiquitous quinone

Eligibility Criteria

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Inclusion Criteria

* Male or female patients with ages between 2 to 18 years old.
* Undergoing regular hemodialysis for at least 6 months.

Exclusion Criteria

* Patients who weigh less than 10 kg.
Minimum Eligible Age

2 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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Salma AbdelRahman

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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El-Demerdash Children's Hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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ACUC-FP-ASU RHDIRB2020110301

Identifier Type: -

Identifier Source: org_study_id

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