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The Effect of CoQ10 Administration on Hemodialysis Patients

Primary Purpose

Chronic Renal Failure, Hemodialysis

Status

Completed

Phase

Phase 4

Locations

Japan

Study Type

Interventional

Intervention

Coenzyme Q10 (drug)

About this trial

This is an interventional treatment trial for Chronic Renal Failure focused on measuring CoQ10, hemodialysis, oxidative marker, antioxidant

Eligibility Criteria

0 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: hemodialysis for at least 6 months Exclusion Criteria: none

Sites / Locations

Iwata City Hospital

Outcomes

Primary Outcome Measures

Oxidative protein concentration at 6 month

Antioxidant capacity at 6 month

Secondary Outcome Measures

Full Information

NCT ID

NCT00307996

First Posted

March 27, 2006

Last Updated

March 27, 2006

Sponsor

University of Shizuoka

1. Study Identification

Unique Protocol Identification Number

NCT00307996

Brief Title

The Effect of CoQ10 Administration on Hemodialysis Patients

Official Title

The Effect of CoQ10 Administration on the Oxidative and Antioxidative Markers in Hemodialysis Patients

Study Type

Interventional

2. Study Status

Record Verification Date

March 2006

Overall Recruitment Status

Completed

Study Start Date

March 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Shizuoka

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Renal Failure, Hemodialysis

Keywords

CoQ10, hemodialysis, oxidative marker, antioxidant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Coenzyme Q10 (drug)

Primary Outcome Measure Information:

Title

Oxidative protein concentration at 6 month

Title

Antioxidant capacity at 6 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

0 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: hemodialysis for at least 6 months Exclusion Criteria: none

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hiromichi Kumagai, MD

Organizational Affiliation

University of Shizuoka

Official's Role

Study Chair

Facility Information:

Facility Name

Iwata City Hospital

City

Iwata

State/Province

Shizuoka

ZIP/Postal Code

438-8550

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

The Effect of CoQ10 Administration on Hemodialysis Patients

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