Coenzyme Q10 in Older Athletes Treated With Statin Medications

Phase 4

Completed

• Conditions: Muscle Weakness; Myalgia; Side Effects of Statins
• Interventions: Drug: placebo; Drug: Coenzyme q 10

• Registration Number: NCT01026311
• Lead Sponsor: Richard Deichmann, MD

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 available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-12-01
• Study First Submitted QC: 2009-12-03
• Study First Posted: 2009-12-04
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-01
• Last Update Posted: 2012-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
placebo	placebo	-
Coenzyme Q10	Coenzyme q 10	200mg of coenzyme Q10

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Ochsner; 🇺🇸 New Orleans, Louisiana, United States