Vitamin B1 against chronic fatigue in inflammatory bowel disease

Thiamin against robust IBD fatigue - The effect of oral thiamin supplement in 4 weeks to patients with inflammatory bowel disease (IBD) in remission and chronic fatigue. A randomised placebo controlled crossover study - TARIF

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002324-17-DK

Enrollment

Registered

2018-07-04

Start date

2018-09-05

Completion date

Unknown

Last updated

2020-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory bowel disease MedDRA version: 20.1 Level: LLT Classification code 10066564 Term: Chronic fatigue System Organ Class: 100000004867

Interventions

Trade Name: Tiamin SAD Pharmaceutical Form: Tablet INN or Proposed INN: Thiamin Other descriptive name: Tiamin DAK Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inflammatory bowel disease Disease in remission Chronic fatigue Age > 17 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: Co-morbidity that can explain fatigue Non-compliant patients Pregnancy Possible surgical intervention

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate if the levels of fatigue can be reduced after 4 weeks treatment with Thiamin, among patients with inflammatory bowel disease in remission and chronic fatigue;Secondary Objective: Investigate determinants for better fatigue levels Investigate the long-trem effect after treatment with thiamin Investigate the long-term effect of low dose thiamin in 12 weeks, after completing high dose thiamin treatment Investigate changes in the patients' health-related quality of life Investigate side effects to the treatment Probably investigate differencies in the patinets microbiome ;Primary end point(s): Reduction in fatigue after 4 weeks treatment with high-dose thiamin;Timepoint(s) of evaluation of this end point: Week 4 or week 12, depending of the randomization	—

Measure

Time frame

Main Objective: To investigate if the levels of fatigue can be reduced after 4 weeks treatment with Thiamin, among patients with inflammatory bowel disease in remission and chronic fatigue;Secondary Objective: Investigate determinants for better fatigue levels Investigate the long-trem effect after treatment with thiamin Investigate the long-term effect of low dose thiamin in 12 weeks, after completing high dose thiamin treatment Investigate changes in the patients' health-related quality of life Investigate side effects to the treatment Probably investigate differencies in the patinets microbiome ;Primary end point(s): Reduction in fatigue after 4 weeks treatment with high-dose thiamin;Timepoint(s) of evaluation of this end point: Week 4 or week 12, depending of the randomization

—

Secondary

Measure	Time frame
Secondary end point(s): Changes in fatigue and/or health-related quality of life Sideeffects;Timepoint(s) of evaluation of this end point: Week 8, 12, 24, and 52	—

Countries

Denmark

Contacts

Public ContactPalle Bager

Aarhus University Hospital

pallbage@rm.dk4551500697

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026