Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2026-02-21 @ 10:01 PM
Study NCT ID:
NCT03634735
Status:
COMPLETED
Last Update Posted:
2020-10-29
First Post:
2018-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thiamin Against Robust IBD Fatigue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013831', 'term': 'Thiamine'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Double blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'RCT and crossover'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-28', 'studyFirstSubmitDate': '2018-06-11', 'studyFirstSubmitQcDate': '2018-08-15', 'lastUpdatePostDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fatigue', 'timeFrame': 'After 4 weeks active treatment', 'description': 'Change in levels of fatigue measured by the Inflammatory Bowel Disease Fatigue Scale (IBD-F). Section I of the scale measures the severity of fatigue on a scale from 0-20, where 20 is maximum fatigue. A change in IBD-F score of 3 points or more is regarded as a clinical relevant change.'}], 'secondaryOutcomes': [{'measure': 'Fatigue', 'timeFrame': 'Week 8, 12, 24, and 52', 'description': 'Change in levels of fatigue measured by the Inflammatory Bowel Disease Fatigue Scale (IBD-F). Section I of the scale measures the severity of fatigue on a scale from 0-20, where 20 is maximum fatigue. A change in IBD-F score of 3 points or more is regarded as a clinical relevant change.'}, {'measure': 'Health-Related Quality of Life', 'timeFrame': 'Week 4, 8, 12, 24, and 52', 'description': 'Changes in Health-Related Quality of Life, measured by the generic EQ-5D Tool (mainly the VAS-scale (0-100, where100 is best).'}, {'measure': 'Disease specific Health-Related Quality of Life', 'timeFrame': 'Week 4, 8, 12, 24, and 52', 'description': 'Changes in Health-Related Quality of Life, measured by the disease specific Short Health Scale (SHS). SHS comprises 4 questions regarding disease related quality of life on VAS-scales (0-10, where 10 is worst).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Inflammatory Bowel Disease', 'Fatigue', 'Thiamine', 'Vitamin B1'], 'conditions': ['Fatigue']}, 'referencesModule': {'references': [{'pmid': '37880581', 'type': 'DERIVED', 'citation': 'Bager P, Hvas CL, Hansen MM, Ueland P, Dahlerup JF. B-vitamins, related vitamers, and metabolites in patients with quiescent inflammatory bowel disease and chronic fatigue treated with high dose oral thiamine. Mol Med. 2023 Oct 25;29(1):143. doi: 10.1186/s10020-023-00741-3.'}, {'pmid': '34592862', 'type': 'DERIVED', 'citation': 'Bager P, Hvas CL, Rud CL, Dahlerup JF. Long-term maintenance treatment with 300 mg thiamine for fatigue in patients with inflammatory bowel disease: results from an open-label extension of the TARIF study. Scand J Gastroenterol. 2022 Jan;57(1):37-43. doi: 10.1080/00365521.2021.1983640. Epub 2021 Sep 30.'}, {'pmid': '33210299', 'type': 'DERIVED', 'citation': 'Bager P, Hvas CL, Rud CL, Dahlerup JF. Randomised clinical trial: high-dose oral thiamine versus placebo for chronic fatigue in patients with quiescent inflammatory bowel disease. Aliment Pharmacol Ther. 2021 Jan;53(1):79-86. doi: 10.1111/apt.16166. Epub 2020 Nov 18.'}]}, 'descriptionModule': {'briefSummary': 'Patients with Inflammatory Bowel Disease (IBD), disease in remission and chronic fatigue will receive oral Thiamine treatment for 4 weeks in a RCT, cross-over study.', 'detailedDescription': 'Patients with Inflammatory Bowel Disease (IBD), disease in remission and chronic fatigue will receive high dose oral Thiamine treatment for 4 weeks in a RCT, cross-over study.\n\nAfter the high dose treatment period, participants will be randomized to 3 months treatment with Thiamine 300mg/day or placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inflammatory Bowel Disease\n* Disease in remission\n* Chronic fatigue\n\nExclusion Criteria:\n\n* Co-morbidity that can explain fatigue\n* Pregnancy\n* Non-compliance to the study procedures\n* Possible surgery in the study period'}, 'identificationModule': {'nctId': 'NCT03634735', 'briefTitle': 'Thiamin Against Robust IBD Fatigue', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Thiamin Against Robust IBD Fatigue', 'orgStudyIdInfo': {'id': 'TARIF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Thiamin', 'description': 'Oral thiamine: 600 - 1800 mg/day in 4 weeks. Dose is depending on gender and age. Tablet contains 300 mg Thiamine each.', 'interventionNames': ['Drug: Thiamine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo: same number of tablets as in the active comparator arm, in 4 weeks', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Thiamine', 'type': 'DRUG', 'otherNames': ['Vitamine B1'], 'description': 'Vitamine B1', 'armGroupLabels': ['Thiamin']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo tablets', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'state': 'Central Region', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}