Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Coenzyme Q10 in Older Athletes Treated With Statin Medications

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01026311
Recruitment Status : Completed
First Posted : December 4, 2009
Last Update Posted : May 3, 2012
Sponsor:
Information provided by (Responsible Party):
Richard Deichmann, MD, Ochsner Health System

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.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : November 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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. ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01026311


Locations
Layout table for location information
United States, Louisiana
Ochsner
New Orleans, Louisiana, United States, 70121
Sponsors and Collaborators
Richard Deichmann, MD
Investigators
Layout table for investigator information
Principal Investigator: Richard Deichmann, MD Ochsner
Layout table for additonal information
Responsible Party: Richard Deichmann, MD, PI, Ochsner Health System
ClinicalTrials.gov Identifier: NCT01026311    
Other Study ID Numbers: 09-076
First Posted: December 4, 2009    Key Record Dates
Last Update Posted: May 3, 2012
Last Verified: May 2012
Keywords provided by Richard Deichmann, MD, Ochsner Health System:
Coenzyme q10
statins
myalgias
anaerobic threshold
athletic performance
Additional relevant MeSH terms:
Layout table for MeSH terms
Muscle Weakness
Myalgia
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Neuromuscular Diseases
Musculoskeletal Pain
Pain
Ubiquinone
Coenzyme Q10
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Vitamins