Coenzyme Q10 in Older Athletes Treated With Statin Medications

NCT01026311 | Completed Phase 4 DMC

• 1 other identifier: 09-076
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Weakness; Myalgia; Side Effects of Statins

Keywords

Coenzyme q10; statins; myalgias; anaerobic threshold; athletic performance

Outcome Measures

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

  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.

Study Arms (2)

placebo

PLACEBO COMPARATOR

Drug: placebo

Coenzyme Q10

ACTIVE COMPARATOR

200mg of coenzyme Q10

Drug: Coenzyme q 10

Interventions

Coenzyme q 10 DRUG

200 mg of Coenzyme q 10

Coenzyme Q10

placebo DRUG

1 placebo q d during treatment period

placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Richard Deichmann, MD: lead

Study Sites (1)

Ochsner

New Orleans, Louisiana, 70121, United States

Location

MeSH Terms

Conditions

Muscle Weakness; Myalgia

Interventions

coenzyme Q10

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neuromuscular Diseases; Musculoskeletal Pain; Pain

Study Officials

• Richard Deichmann, MD

  Ochsner

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: December 1, 2009
• First Posted: December 4, 2009
• Study Start: November 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: May 3, 2012

Record last verified: 2012-05

Locations

US (1)