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NCT05170893 Clinical Trial

Efficacy and Safety of Coenzyme Q10 in Pediatric Hemodialysis Patients

Hemodialysis Clinical Trial

Official title:
Efficacy and Safety of Coenzyme Q10 in Pediatric Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05170893
Other study ID # ACUC-FP-ASU RHDIRB2020110301
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 17, 2022
Est. completion date July 26, 2022

Study information
Verified date July 2023
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date July 26, 2022
Est. primary completion date July 14, 2022
Accepts healthy volunteers No
Gender All
Age group 2 Years to 18 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Coenzyme Q10
Oral capsules
Other:
• Placebo
Oral capsules

Locations
Country Name City State
Egypt El-Demerdash Children's Hospital Cairo

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Malondialdehyde (MDA) marker of oxidative stress 12 weeks
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