Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2025-12-26 @ 1:48 AM
Study NCT ID:
NCT00067405
Status:
COMPLETED
Last Update Posted:
2008-04-22
First Post:
2003-08-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intravenous Micronutrient Therapy (IVMT) for Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-04-21', 'studyFirstSubmitDate': '2003-08-18', 'studyFirstSubmitQcDate': '2003-08-19', 'lastUpdatePostDateStruct': {'date': '2008-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Fibromyalgia', 'Intravenous micronutrient therapy', 'IVMT', 'alternative medicine', 'complementary medicine', 'vitamins', 'vitamin supplements'], 'conditions': ['Fibromyalgia']}, 'referencesModule': {'references': [{'pmid': '19250003', 'type': 'DERIVED', 'citation': "Ali A, Njike VY, Northrup V, Sabina AB, Williams AL, Liberti LS, Perlman AI, Adelson H, Katz DL. Intravenous micronutrient therapy (Myers' Cocktail) for fibromyalgia: a placebo-controlled pilot study. J Altern Complement Med. 2009 Mar;15(3):247-57. doi: 10.1089/acm.2008.0410."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if intravenous micronutrient therapy (IVMT) is effective in the treatment of fibromyalgia, as assessed by validated functional and pain measures.', 'detailedDescription': 'As per Brief Summary'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Meet the American College of Rheumatology criteria for Fibromyalgia diagnosis;\n* On no medication for Fibromyalgia other than acetaminophen, or willing to stop all such medication for the duration of the study\n\n * Willing to stop all FMS medication for the duration of the study or be on a stable dose of such medication for at least 3 months\n\nExclusion criteria:\n\n* Other concurrent medical conditions such as rheumatologic disease, chronic infection, untreated endocrine disorders, unstable seizures, psychiatric disorders, acute peptic ulcer disease, congestive heart failure, chronic liver disorders and/or bleeding problems\n\n * Allergy to thiamin\n* Unwilling to stop vitamin supplementation for the duration of the study\n\n * PLEASE NOTE: Travel to and accomodations at the study site can NOT be compensated. Anyone wishing to travel from outside of the study site's geographic area must do so at their own risk and expense."}, 'identificationModule': {'nctId': 'NCT00067405', 'briefTitle': 'Intravenous Micronutrient Therapy (IVMT) for Fibromyalgia', 'organization': {'class': 'NIH', 'fullName': 'National Center for Complementary and Integrative Health (NCCIH)'}, 'officialTitle': 'Intravenous Micronutrient Therapy (IVMT) for Fibromyalgia', 'orgStudyIdInfo': {'id': 'R21AT000942-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R21AT000942-01A1', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'Katz'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Intravenous micronutrient therapy', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06418', 'city': 'Derby', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale-Griffin Prevention Research Center', 'geoPoint': {'lat': 41.32065, 'lon': -73.089}}], 'overallOfficials': [{'name': 'David Katz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale-Griffin Prevention Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}}}}