Coenzyme Q10 in Older Athletes Treated With Statin Medications

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Richard Deichmann, MD, Ochsner Health System
ClinicalTrials.gov Identifier:
NCT01026311
First received: December 1, 2009
Last updated: May 1, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Muscle Weakness
Myalgia
Side Effects of Statins
Drug: Coenzyme q 10
Drug: placebo
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Ochsner Health System:

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 [ 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. ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: November 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo Drug: placebo
1 placebo q d during treatment period
Active Comparator: Coenzyme Q10
200mg of coenzyme Q10
Drug: Coenzyme q 10
200 mg of Coenzyme q 10

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01026311

Locations
United States, Louisiana
Ochsner
New Orleans, Louisiana, United States, 70121
Sponsors and Collaborators
Richard Deichmann, MD
Investigators
Principal Investigator: Richard Deichmann, MD Ochsner
  More Information

No publications provided

Responsible Party: Richard Deichmann, MD, PI, Ochsner Health System
ClinicalTrials.gov Identifier: NCT01026311     History of Changes
Other Study ID Numbers: 09-076
Study First Received: December 1, 2009
Last Updated: May 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Ochsner Health System:
Coenzyme q10
statins
myalgias
anaerobic threshold
athletic performance

Additional relevant MeSH terms:
Asthenia
Muscle Weakness
Paresis
Myalgia
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Musculoskeletal Pain
Pain
Neuromuscular Diseases
Coenzyme Q10
Ubiquinone
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Vitamins

ClinicalTrials.gov processed this record on August 20, 2014