Thiamin Against Robust IBD Fatigue
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2018
CompletedFirst Posted
Study publicly available on registry
August 16, 2018
CompletedStudy Start
First participant enrolled
November 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 21, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 27, 2020
CompletedOctober 29, 2020
October 1, 2020
1.4 years
June 11, 2018
October 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fatigue
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.
After 4 weeks active treatment
Secondary Outcomes (3)
Fatigue
Week 8, 12, 24, and 52
Health-Related Quality of Life
Week 4, 8, 12, 24, and 52
Disease specific Health-Related Quality of Life
Week 4, 8, 12, 24, and 52
Study Arms (2)
Thiamin
ACTIVE COMPARATOROral thiamine: 600 - 1800 mg/day in 4 weeks. Dose is depending on gender and age. Tablet contains 300 mg Thiamine each.
Placebo
PLACEBO COMPARATORPlacebo: same number of tablets as in the active comparator arm, in 4 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Inflammatory Bowel Disease
- Disease in remission
- Chronic fatigue
You may not qualify if:
- Co-morbidity that can explain fatigue
- Pregnancy
- Non-compliance to the study procedures
- Possible surgery in the study period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aarhus University Hospital
Aarhus, Central Region, 8000, Denmark
Related Publications (3)
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: 37880581DERIVEDBager 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: 34592862DERIVEDBager 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.
PMID: 33210299DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Double blinded
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2018
First Posted
August 16, 2018
Study Start
November 27, 2018
Primary Completion
April 21, 2020
Study Completion
October 27, 2020
Last Updated
October 29, 2020
Record last verified: 2020-10