Efficacy and Safety of Coenzyme Q10 in Pediatric Hemodial... | NCT05170893

Studies
Efficacy and Safety of Coenzyme Q10 in Pediatric Hemodialysis Patients

NCT05170893

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Jul 19, 2023Actual

Enrollment

36Actual

Phase

Not Applicable

Conditions

Hemodialysis

Interventions

Coenzyme Q10
Placebo

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 17, 2022Actual

Primary Completion Date

Jul 14, 2022Actual

Completion Date

Jul 26, 2022Actual

First Submitted Date

Dec 11, 2021

First Submission Date that Met QC Criteria

Dec 11, 2021

First Posted Date

Dec 28, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2023

Last Update Posted Date

Jul 19, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Coenzyme Q10	Dietary Supplement	Oral capsules	Intervention group	ubiquinone, ubidecarenone, ubiquitous quinone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Malondialdehyde (MDA)	marker of oxidative stress	12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
El-Demerdash Children's Hospital		Cairo			Egypt

Intervention Browse Module

MeSH Terms

ID	Term
C024989	coenzyme Q10
D014451	Ubiquinone

Ancestor Terms

ID	Term
D016227	Benzoquinones
D011809	Quinones
D009930	Organic Chemicals
D003067	Coenzymes

Browse Leaves

Not provided

Browse Branches

Not provided