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| ID | Type | Description | Link |
|---|---|---|---|
| AT004204 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CoQ-10 supplementation | Experimental |
| |
| CoQ-10 placebo supplementation | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Co-enzyme Q-10 | Dietary Supplement | Patients will be supplemented with 300 mg of CoQ-10 1 time daily for one month |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain scores should be reduced | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Caso, MD, PhD | Stony Brook University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stony Brook University GCRC | Stony Brook | New York | 11794 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D001247 | Asthenia |
| D005221 | Fatigue |
| D063806 | Myalgia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
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| ID | Term |
|---|---|
| D014451 | Ubiquinone |
| ID | Term |
|---|---|
| D016227 | Benzoquinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
| D003067 | Coenzymes |
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| Placebo | Dietary Supplement | Patients will be supplemented with CoQ-10 placebo 1 time daily for one month |
|
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D059352 | Musculoskeletal Pain |
| D045762 |
| Enzymes and Coenzymes |