Coenzyme Q10 in Older Athletes Treated With Statin Medications

Muscle Weakness Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01026311
• Other study ID #: 09-076
• Status: Completed
• Phase: Phase 4
• First received: December 1, 2009
• Last updated: May 1, 2012
• Start date: November 2009
• Est. completion date: March 2011

Study information

• Verified date: May 2012
• Source: Ochsner Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Weakness
• Myalgia
• Paresis
• Side Effects of Statins

Intervention

Drug:
• Coenzyme q 10
200 mg of Coenzyme q 10
• placebo
1 placebo q d during treatment period

Locations

Country	Name	City	State
United States	Ochsner	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Richard Deichmann, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No