Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-30 @ 2:58 PM
Study NCT ID:
NCT01274104
Status:
WITHDRAWN
Last Update Posted:
2015-04-22
First Post:
2011-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study on the Effect of Vitamin D Treatment in Patients With Statin-Associated Myalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}], 'ancestors': [{'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'PI resigned.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-21', 'studyFirstSubmitDate': '2011-01-06', 'studyFirstSubmitQcDate': '2011-01-07', 'lastUpdatePostDateStruct': {'date': '2015-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brief Pain Inventory value', 'timeFrame': '14 days', 'description': 'Decrease in the level of muscle pain, based on values of Brief Pain Inventory short forms completed at the initial clinic visit and approximately four weeks later at the final clinic visit'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['statin-related myalgia', 'high cholesterol'], 'conditions': ['Hyperlipidemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to measure the effect vitamin D has in alleviating muscle pain or aches that may be caused by taking certain medications for treating high cholesterol.', 'detailedDescription': 'Participation in this study will consist of at least two study visits, expected to occur over a period of up to four weeks. Study-related medication will be provided at no cost to participants. Participants will receive either Vitamin D or placebo (sugar pill).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '88 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women who are between the ages of 18 and 88 years old\n* A muscle symptom defined as any of the following: Myalgia (muscle aches with normal CK); Myopathy (muscle aches with increased CK up to 5 times above the upper limit of normal); or Myopathy for the purpose of further evaluation (muscle aches with increased CK up to 5 times the upper limit of normal)\n\nExclusion Criteria:\n\n* Women who are pregnant, breastfeeding or planning to become pregnant\n* Morbidly obese with a BMI \\>40 kg/m2\n* Travel to southern states, areas near the Equator, etc., or use of artificial tanning beds, such that study participants have increased sunlight/UV rays exposure in the past 30 days or at any point during the trial\n* Currently (within the last 2 weeks) using any of the following supplements: Vitamin D-3 (Cholecalciferol) of more than 400 IU orally daily, which would not exclude typical multi-vitamin use; Vitamin D-2 (Ergocalciferol); Calcitriol; or Coenzyme Q10\n* Documented to be hyperglycemic or laboratory results show hyperglycemia prior to randomization\n* Renal dysfunction defined as glomerular filtration rate less than 60 mL/min.\n* Documented to have parathyroid abnormalities or parathyroid hormone laboratory results show the study participant is outside of the normal limits'}, 'identificationModule': {'nctId': 'NCT01274104', 'briefTitle': 'A Pilot Study on the Effect of Vitamin D Treatment in Patients With Statin-Associated Myalgia', 'organization': {'class': 'OTHER', 'fullName': 'Avera McKennan Hospital & University Health Center'}, 'officialTitle': 'A Pilot Study on the Effect of Vitamin D Treatment in Patients With Statin-Associated Myalgia', 'orgStudyIdInfo': {'id': 'ARI-1350-Myalgia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin D', 'description': 'Subjects will take 5,000 IU-capsules of vitamin D3 three times a day (for a total of 15,000 IU) for 14 days', 'interventionNames': ['Dietary Supplement: Vitamin D3']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Subjects will take 3 capsules of placebo every day for 14 days', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Vitamin D3', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Cholecalciferol'], 'description': '15,000 IU of Vitamin D3 every day for 14 days', 'armGroupLabels': ['Vitamin D']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57105', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Avera Research Institute', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}], 'overallOfficials': [{'name': 'Wael Eid, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Avera McKennan Hospital & University Health Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avera McKennan Hospital & University Health Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Wael Eid, MD', 'oldOrganization': 'Avera McKennan Hospital & University Health Center'}}}}