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Benefit of CoQ-10 in Patients on Statins

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Stony Brook University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Stony Brook University
ClinicalTrials.gov Identifier:
NCT00997269
First received: October 16, 2009
Last updated: August 11, 2011
Last verified: August 2011

October 16, 2009
August 11, 2011
September 2009
February 2012   (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
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
68
July 2012
February 2012   (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: Giuseppe Caso, MD, PhD (631) 444-1790 gcaso@notes.cc.sunysb.edu
Contact: Teresa Hunt-Goncalves, NP (631) 444-9362 thunt_goncalves@notes.cc.sunysb.edu
United States
 
NCT00997269
2008-0436, AT004204
Yes
Giuseppe Caso, MD, PhD, Stony Brook University
Stony Brook University
Not Provided
Principal Investigator: Giuseppe Caso, MD, PhD Stony Brook University
Stony Brook University
August 2011

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