The Effect of CoQ10 Administration on Hemodialysis Patients | NCT00307996

Studies
The Effect of CoQ10 Administration on Hemodialysis Patients

NCT00307996

Sponsor

University of Shizuoka

Status

Completed

Last Update Posted

Mar 28, 2006Estimated

Enrollment

Phase

Phase 4

Conditions

Chronic Renal Failure
Hemodialysis

Interventions

Coenzyme Q10 (drug)

Countries

Japan

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

Mar 2006

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

Mar 2004

Primary Completion Date

Not provided

Completion Date

Dec 2004

First Submitted Date

Mar 27, 2006

First Submission Date that Met QC Criteria

Mar 27, 2006

First Posted Date

Mar 28, 2006Estimated

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

Mar 27, 2006

Last Update Posted Date

Mar 28, 2006Estimated

Description Module

Brief Summary

The purpose of this study is to examine whether CoQ10 administration is effective as an antioxidant in hemodialysis patients.

Detailed Description

Oxidative stress has been recognized as a potential risk factor for such complications as atherosclerosis in hemodialysis patients. This study investigates whether CoQ10 administration is effective for protecting oxidative stress in hemodialysis patients. The subjects were recruited from day-time hemodialysis patients in Iwata City Hospital. 100 mg CoQ10 was administered every HD for 6 months. Several oxidative and antioxidative markers were measured in plasma at pre, 1, 3, 6 months and after washout.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Coenzyme Q10 (drug)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Oxidative protein concentration at 6 month
Antioxidant capacity at 6 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

hemodialysis for at least 6 months

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

85 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hiromichi Kumagai, MD	University of Shizuoka	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Iwata City Hospital		Iwata	Shizuoka	438-8550	Japan

Condition Browse Module

MeSH Terms

ID	Term
D007676	Kidney Failure, Chronic

Ancestor Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C024989	coenzyme Q10
D004364	Pharmaceutical Preparations

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided