Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-04-11 @ 5:27 AM
Study NCT ID:
NCT00997269
Status:
COMPLETED
Last Update Posted:
2016-05-02
First Post:
2009-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Benefit of CoQ-10 in Patients on Statins
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D001247', 'term': 'Asthenia'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D063806', 'term': 'Myalgia'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D059352', 'term': 'Musculoskeletal Pain'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014451', 'term': 'Ubiquinone'}], 'ancestors': [{'id': 'D016227', 'term': 'Benzoquinones'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-28', 'studyFirstSubmitDate': '2009-10-16', 'studyFirstSubmitQcDate': '2009-10-16', 'lastUpdatePostDateStruct': {'date': '2016-05-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain scores should be reduced', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CoQ-10', 'statin', 'muscle pain', 'cardiovascular'], 'conditions': ['Pain', 'Soreness', 'Weakness', 'Fatigue']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis 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.\n\nSpecific 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.\n\nThis aim will be addressed by analyzing muscle biopsies taken from statin-treated patients before and after supplementation with coQ10 or placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 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.\n\nExclusion Criteria:\n\n1. diagnosis of cancer;\n2. acute illness of any sort;\n3. hemoglobin less than 12,\n4. creatinine greater than 1.5 mg/dl;\n5. liver dysfunction as evidenced by elevations in transaminases 3-fold higher than upper limit of normal;\n6. use of certain medications or nutritional supplements within the past month;\n7. untreated hypertension (diastolic BP\\> 100 mm HG);\n8. diagnosis of diabetes mellitus (fasting blood glucose \\> 126 mg/dl);\n9. untreated hypothyroidism;\n10. overt congestive heart failure (by physical exam);\n11. active inflammatory diseases such as rheumatoid arthritis, lupus, etc.,\n12. bleeding disorders;\n13. history of adverse reactions besides myopathy associated with the use of statins;\n14. any previous adverse reaction to coQ10 or to multivitamin supplements containing coQ10;\n15. plasma CPK levels \\> 3 times the upper normal limit; OR\n16. congenital myopathies and/or neuromuscular degenerative diseases.'}, 'identificationModule': {'nctId': 'NCT00997269', 'acronym': 'CoQ-10', 'briefTitle': 'Benefit of CoQ-10 in Patients on Statins', 'organization': {'class': 'OTHER', 'fullName': 'Stony Brook University'}, 'officialTitle': 'Benefit of CoQ-10 in Patients on Statins', 'orgStudyIdInfo': {'id': '2008-0436'}, 'secondaryIdInfos': [{'id': 'AT004204'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CoQ-10 supplementation', 'interventionNames': ['Dietary Supplement: Co-enzyme Q-10']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'CoQ-10 placebo supplementation', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Co-enzyme Q-10', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['ubiquinone'], 'description': 'Patients will be supplemented with 300 mg of CoQ-10 1 time daily for one month', 'armGroupLabels': ['CoQ-10 supplementation']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients will be supplemented with CoQ-10 placebo 1 time daily for one month', 'armGroupLabels': ['CoQ-10 placebo supplementation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Stony Brook University GCRC', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}], 'overallOfficials': [{'name': 'Giuseppe Caso, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stony Brook University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stony Brook University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}