NCT05170893

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

December 11, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 28, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

January 17, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2022

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2022

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

December 11, 2021

Last Update Submit

July 18, 2023

Conditions

Hemodialysis

Outcome Measures

Primary Outcomes (1)

  • Change in Malondialdehyde (MDA)

    marker of oxidative stress

    12 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Oral Coenzyme Q10 capsules daily for 12 weeks.

Dietary Supplement: Coenzyme Q10

Control group

PLACEBO COMPARATOR

Oral capsules similar to the intervention daily for 12 weeks.

Other: Placebo

Interventions

Coenzyme Q10DIETARY_SUPPLEMENT

Oral capsules

Also known as: ubiquinone, ubidecarenone, ubiquitous quinone
Intervention group
PlaceboOTHER

Oral capsules

Control group

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Patients who weigh less than 10 kg.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

El-Demerdash Children's Hospital

Cairo, Egypt

Location

MeSH Terms

Interventions

coenzyme Q10Ubiquinone

Intervention Hierarchy (Ancestors)

BenzoquinonesQuinonesOrganic ChemicalsCoenzymesEnzymes and Coenzymes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 11, 2021

First Posted

December 28, 2021

Study Start

January 17, 2022

Primary Completion

July 14, 2022

Study Completion

July 26, 2022

Last Updated

July 19, 2023

Record last verified: 2023-07

Locations

EG(1)