Status:
COMPLETED
Benefit of CoQ-10 in Patients on Statins
Lead Sponsor:
Stony Brook University
Conditions:
Pain
Soreness
Eligibility:
All Genders
21+ years
Phase:
NA
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 ...
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. Thi...
Eligibility Criteria
Inclusion
- 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
- diagnosis of cancer;
- acute illness of any sort;
- hemoglobin less than 12,
- creatinine greater than 1.5 mg/dl;
- liver dysfunction as evidenced by elevations in transaminases 3-fold higher than upper limit of normal;
- use of certain medications or nutritional supplements within the past month;
- untreated hypertension (diastolic BP\> 100 mm HG);
- diagnosis of diabetes mellitus (fasting blood glucose \> 126 mg/dl);
- untreated hypothyroidism;
- overt congestive heart failure (by physical exam);
- active inflammatory diseases such as rheumatoid arthritis, lupus, etc.,
- bleeding disorders;
- history of adverse reactions besides myopathy associated with the use of statins;
- any previous adverse reaction to coQ10 or to multivitamin supplements containing coQ10;
- plasma CPK levels \> 3 times the upper normal limit; OR
- congenital myopathies and/or neuromuscular degenerative diseases.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00997269
Start Date
September 1 2009
End Date
July 1 2014
Last Update
May 2 2016
Active Locations (1)
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1
Stony Brook University GCRC
Stony Brook, New York, United States, 11794