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Completed

NCT Number: NCT01026311

Coenzyme Q10 in Older Athletes Treated With Statin Medications

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.

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Key information

Conditions

Muscle Weakness Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Myalgia Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Neuromuscular Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Side Effects of Statins Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ochsner

New Orleans, Louisiana, 70121, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coenzyme q 10

Drug

200 mg of Coenzyme q 10

Placebo

Drug

1 placebo q d during treatment period

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Richard Deichmann, MD

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 4, 2009
Registry last updated
May 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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