Coenzyme Q10 in Older Athletes Treated With Statin Medications

NCT ID: NCT01026311

Last Updated: 2012-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-03-31

Brief Summary

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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

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Conditions

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Muscle Weakness Myalgia Side Effects of Statins

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

1 placebo q d during treatment period

Coenzyme Q10

200mg of coenzyme Q10

Group Type ACTIVE_COMPARATOR

Coenzyme q 10

Intervention Type DRUG

200 mg of Coenzyme q 10

Interventions

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Coenzyme q 10

200 mg of Coenzyme q 10

Intervention Type DRUG

placebo

1 placebo q d during treatment period

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Richard Deichmann, MD

OTHER

Sponsor Role lead

Responsible Party

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Richard Deichmann, MD

PI

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Richard Deichmann, MD

Role: PRINCIPAL_INVESTIGATOR

Ochsner

Locations

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Ochsner

New Orleans, Louisiana, United States

Site Status

Countries

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United States

Other Identifiers

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09-076

Identifier Type: -

Identifier Source: org_study_id

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