Coenzyme Q10 in Older Athletes Treated With Statin Medica... | NCT01026311

Studies
Coenzyme Q10 in Older Athletes Treated With Statin Medications

NCT01026311

Sponsor

Richard Deichmann, MD

Status

Completed

Last Update Posted

May 3, 2012Estimated

Enrollment

20Actual

Phase

Phase 4

Conditions

Muscle Weakness
Myalgia
Side Effects of Statins

Interventions

Coenzyme q 10
placebo

Countries

United States

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2012

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

Nov 2009

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Dec 1, 2009

First Submission Date that Met QC Criteria

Dec 3, 2009

First Posted Date

Dec 4, 2009Estimated

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

May 1, 2012

Last Update Posted Date

May 3, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this study is to evaluate the effect of coenzyme Q10 administration in improving mitochondrial function as measured by anaerobic threshold in older athletes on a stable dose of statin medication.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
placebo	Placebo Comparator		Drug: placebo
Coenzyme Q10	Active Comparator	200mg of coenzyme Q10	Drug: Coenzyme q 10

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Coenzyme q 10	Drug	200 mg of Coenzyme q 10	Coenzyme Q10
placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary objective of this study is to test if oral coenzyme Q10 is superior to placebo in improving oxygen consumption by mitochondria as measured by cardiopulmonary fitness testing for anaerobic threshold in this population		The study will consist of an initial six week treatment period followed by a six week washout period. Subjects will then crossover to the alternative treatment for a second six week study period.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients ≥ 50 years of age, male or female.
Patients on a stable dose of statin medication for at least 3 months prior to enrollment in the study
Self-Described Athletes with any of the following characteristics:
- Participation in a competitive athletic event within the past year or currently training for a competitive athletic event within the 6 months following enrollment
- Regular exercise activity of at least 45 minutes duration 5 times per week

Exclusion Criteria:

Use of coenzyme Q10 during the preceding two months.
CPK level at baseline greater than two times the upper limits of normal
LDL level at baseline greater than 160 for those without a cardiovascular risk or cardiovascular risk equivalent
LDL level at baseline greater than 130 for those with a cardiovascular risk or cardiovascular risk equivalent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Richard Deichmann, MD	Ochsner	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Ochsner		New Orleans	Louisiana	70121	United States

Type	Date	Date Unknown
Release	Sep 4, 2020
Reset	Sep 25, 2020
Release	Apr 4, 2023
Reset	Apr 25, 2023

Condition Browse Module

MeSH Terms

ID	Term
D018908	Muscle Weakness
D063806	Myalgia

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D020879	Neuromuscular Manifestations
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Sep 4, 2020			Sep 25, 2020
Apr 4, 2023