- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00997269
Benefit of CoQ-10 in Patients on Statins (CoQ-10)
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Stony Brook, New York, United States, 11794
- Stony Brook University GCRC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CoQ-10 supplementation
|
Patients will be supplemented with 300 mg of CoQ-10 1 time daily for one month
Other Names:
|
Placebo Comparator: CoQ-10 placebo supplementation
|
Patients will be supplemented with CoQ-10 placebo 1 time daily for one month
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain scores should be reduced
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Giuseppe Caso, MD, PhD, Stony Brook University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008-0436
- AT004204
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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