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Coenzyme Q10 in Older Athletes Treated With Statin Medications

Primary Purpose

Muscle Weakness, Myalgia, Side Effects of Statins

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Coenzyme q 10
placebo
Sponsored by
Richard Deichmann, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Weakness focused on measuring Coenzyme q10, statins, myalgias, anaerobic threshold, athletic performance

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ochsner

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

placebo

Coenzyme Q10

Arm Description

200mg of coenzyme Q10

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 1, 2009
Last Updated
May 1, 2012
Sponsor
Richard Deichmann, MD
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1. Study Identification

Unique Protocol Identification Number
NCT01026311
Brief Title
Coenzyme Q10 in Older Athletes Treated With Statin Medications
Official Title
A Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Efficacy of Coenzyme Q10 in Improving Mitochondrial Function in Older Athletes Treated With Statin Medications
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Richard Deichmann, MD

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness, Myalgia, Side Effects of Statins
Keywords
Coenzyme q10, statins, myalgias, anaerobic threshold, athletic performance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Title
Coenzyme Q10
Arm Type
Active Comparator
Arm Description
200mg of coenzyme Q10
Intervention Type
Drug
Intervention Name(s)
Coenzyme q 10
Intervention Description
200 mg of Coenzyme q 10
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
1 placebo q d during treatment period
Primary Outcome Measure Information:
Title
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
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Deichmann, MD
Organizational Affiliation
Ochsner
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ochsner
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States

12. IPD Sharing Statement

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Coenzyme Q10 in Older Athletes Treated With Statin Medications

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