Benefit of CoQ-10 in Patients on Statins (CoQ-10)

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. Identifier: NCT00997269
Recruitment Status : Completed
First Posted : October 19, 2009
Last Update Posted : May 2, 2016
Information provided by (Responsible Party):
Stony Brook University

Brief Summary:
This study will investigate whether a supplement called co-enzyme Q10 can help ease or eliminate some of the side effects that result from taking statin medications. These side effects include muscle pain, fatigue or muscle cramping.

Condition or disease Intervention/treatment Phase
Pain Soreness Weakness Fatigue Dietary Supplement: Co-enzyme Q-10 Dietary Supplement: Placebo Not Applicable

Detailed Description:

Specific Aim 1: to demonstrate that supplementation with coQ10 in patients treated with statins ameliorates symptoms of muscle pain and fatigue and improves energy metabolism and muscle function.

This objective will be achieved in a randomized, placebo-controlled double blind trial by assessing the degree of muscle symptoms and interference of pain with daily activities, aerobic capacity, and muscle function before and after supplementation with either coQ10 or placebo in groups of statin-treated subjects.

Specific Aim 2: to examine changes at a molecular/cellular level that are associated with improved pain and muscle function in statin-treated subjects supplemented with coQ10.

This aim will be addressed by analyzing muscle biopsies taken from statin-treated patients before and after supplementation with coQ10 or placebo.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Benefit of CoQ-10 in Patients on Statins
Study Start Date : September 2009
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: CoQ-10 supplementation Dietary Supplement: Co-enzyme Q-10
Patients will be supplemented with 300 mg of CoQ-10 1 time daily for one month
Other Name: ubiquinone

Placebo Comparator: CoQ-10 placebo supplementation Dietary Supplement: Placebo
Patients will be supplemented with CoQ-10 placebo 1 time daily for one month

Primary Outcome Measures :
  1. Pain scores should be reduced [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Adult men and women 21 years and older taking statin medications for hyperlipidemia under the current National Cholesterol Education Program guidelines (NCEP III) and complaining of myopathic symptoms.

Exclusion Criteria:

  1. diagnosis of cancer;
  2. acute illness of any sort;
  3. hemoglobin less than 12,
  4. creatinine greater than 1.5 mg/dl;
  5. liver dysfunction as evidenced by elevations in transaminases 3-fold higher than upper limit of normal;
  6. use of certain medications or nutritional supplements within the past month;
  7. untreated hypertension (diastolic BP> 100 mm HG);
  8. diagnosis of diabetes mellitus (fasting blood glucose > 126 mg/dl);
  9. untreated hypothyroidism;
  10. overt congestive heart failure (by physical exam);
  11. active inflammatory diseases such as rheumatoid arthritis, lupus, etc.,
  12. bleeding disorders;
  13. history of adverse reactions besides myopathy associated with the use of statins;
  14. any previous adverse reaction to coQ10 or to multivitamin supplements containing coQ10;
  15. plasma CPK levels > 3 times the upper normal limit; OR
  16. congenital myopathies and/or neuromuscular degenerative diseases.

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 identifier (NCT number): NCT00997269

United States, New York
Stony Brook University GCRC
Stony Brook, New York, United States, 11794
Sponsors and Collaborators
Stony Brook University
Principal Investigator: Giuseppe Caso, MD, PhD Stony Brook University

Responsible Party: Stony Brook University Identifier: NCT00997269     History of Changes
Other Study ID Numbers: 2008-0436
First Posted: October 19, 2009    Key Record Dates
Last Update Posted: May 2, 2016
Last Verified: April 2016

Keywords provided by Stony Brook University:
muscle pain

Additional relevant MeSH terms:
Signs and Symptoms
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Coenzyme Q10
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents
Growth Substances
Physiological Effects of Drugs