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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stony Brook University
ClinicalTrials.gov Identifier:
NCT00997269
First received: October 16, 2009
Last updated: April 28, 2016
Last verified: April 2016

October 16, 2009
April 28, 2016
September 2009
July 2014   (final data collection date for primary outcome measure)
Pain scores should be reduced [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00997269 on ClinicalTrials.gov Archive Site
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Benefit of CoQ-10 in Patients on Statins
Benefit of CoQ-10 in Patients on Statins
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.

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.

Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Pain
  • Soreness
  • Weakness
  • Fatigue
  • 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
  • Dietary Supplement: Placebo
    Patients will be supplemented with CoQ-10 placebo 1 time daily for one month
  • Experimental: CoQ-10 supplementation
    Intervention: Dietary Supplement: Co-enzyme Q-10
  • Placebo Comparator: CoQ-10 placebo supplementation
    Intervention: Dietary Supplement: Placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
July 2014
July 2014   (final data collection date for primary outcome measure)

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.
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00997269
2008-0436, AT004204
Yes
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Stony Brook University
Stony Brook University
Not Provided
Principal Investigator: Giuseppe Caso, MD, PhD Stony Brook University
Stony Brook University
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP