Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2026-04-17 @ 11:36 AM
Study NCT ID:
NCT01523106
Status:
WITHDRAWN
Last Update Posted:
2014-01-17
First Post:
2012-01-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
L-carnitine to Treat Fatigue Associated With Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002331', 'term': 'Carnitine'}], 'ancestors': [{'id': 'D050337', 'term': 'Trimethyl Ammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-01-16', 'studyFirstSubmitDate': '2012-01-18', 'studyFirstSubmitQcDate': '2012-01-28', 'lastUpdatePostDateStruct': {'date': '2014-01-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in fatigue severity scale', 'timeFrame': 'From baseline to 3 months after intervention initiation', 'description': 'The Fatigue Severity Score is a validated instrument to assess fatigue associated with chronic disease. The scale ranges from scores from 9 to 63, with a higher score indicated greater fatigue.'}], 'secondaryOutcomes': [{'measure': 'Change in Multidimensional Fatigue Inventory', 'timeFrame': 'From baseline to 3 months after intevention initiation', 'description': 'This is a validated instrument to measure fatigue and has been validated for use for patients with inflammatory bowel disease. Scores range from 4-20, with higher scores indicated more severe fatigue.'}, {'measure': 'Change in handgrip strength', 'timeFrame': 'From baseline to 3 months after treatment intervention', 'description': 'Handgrip strength will be assessed by a portable dynanometer. Maximal force after three tries will be recorded.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Crohn's disease", 'carnitine'], 'conditions': ["Crohn's Disease", 'Fatigue']}, 'descriptionModule': {'briefSummary': "This is a randomized, double-blind, placebo-controlled study, comparing the effect of L-carnitine vs placebo on fatigue among Crohn's disease patients.\n\nThe specific aim of this study is to determine if treatment with L-carnitine is more effective than placebo at decreasing fatigue severity scores, while accounting for disease activity and concomitant anemia, depression/anxiety and poor sleep quality.", 'detailedDescription': 'A total of 100 patients will be recruited, in order to be able ensure to detect a significant difference in fatigue between the treatment and control groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients will have had previously macro- and microscopically verified Crohn\'s disease, as defined by traditional clinical and endoscopic standards.\n* To be included, patients need to have disease which is either in remission or is mild to moderate in severity, as defined by the Harvey-Bradshaw Index Score (HBI\\<16).\n* In addition, patients will need to answer "yes" to the screening study entry question ("Is fatigue a signficant problem for you currently?").\n\nExclusion Criteria:\n\n* Exclusion criteria will include:\n\n * age \\<18 or \\>70 years\n * pregnancy or delivery within 6 months\n * malignancy diagnosed within 1 year\n * oral/intravenous steroid treatment within 6 months\n * any surgery within 6 months\n * presence of a stoma or ileo-anal J-pouch anastomosis\n * concurrent hepatitis B or C infection\n * cirrhosis\n * renal insufficiency (CrCl\\<60) and history of seizure disorder or hypothyrodism.\n * prior to study enrollment\n * women of child-bearing age will need to undergo pregnancy testing.'}, 'identificationModule': {'nctId': 'NCT01523106', 'briefTitle': "L-carnitine to Treat Fatigue Associated With Crohn's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': "L-carnitine to Treat Fatigue Associated With Crohn's Disease", 'orgStudyIdInfo': {'id': "carnitine and crohn's disease"}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Carnitine', 'description': 'Patients will take 4grams of L-carnitine (2 grams twice daily) for 3 months', 'interventionNames': ['Drug: L-carnitine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients will take placebo for 3 months. Placebo is manufactured by the same company as the L-carnitine and will have a similar appearance.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'L-carnitine', 'type': 'DRUG', 'description': 'dietary supplement', 'armGroupLabels': ['Carnitine']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Patients will receive placebo, which will be manufactured by the same supplier as L-carnitine and appears identical. Patients will take an equal number of pills (8 pills/day).', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Medical Center, Mt. Zion Medical Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Uma Mahadevan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}