Vitamin B1 as treatment for chronic fatigue in patients with primary biliary cholangitis

PBC induced fatigue treated with thiamine - The effect of oral thiamine supplement in 4 weeks to patients with primary biliary cholangitis (PBC) and chronic fatigue. A randomised, double-blinded, placebo-controlled, crossover study - PIFT

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-004935-26-DK

Enrollment

Registered

2020-12-09

Start date

2021-02-25

Completion date

Unknown

Last updated

2021-03-30

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

Conditions

Primary biliary cholangitis MedDRA version: 21.0 Level: PT Classification code 10080429 Term: Primary biliary cholangitis System Organ Class: 10019805 - Hepatobiliary disorders 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: THIAMINE CAS Number: 59-43-8 Other descriptive name: Tiamin DAK Concentration unit: mg milligram(s) Concentration type: equal Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: PBC > 3 months Chronic fatigue (PBC-40, fatigue score > 32) Age of 18 years or more 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 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 18

Exclusion criteria

Exclusion criteria: Comorbidity that can explain fatigue Non-compliant patients Pregnancy Expected surgical intervention during the study period Chronic kidney disease (GFR<60)

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate if the levels of fatigue can be reduced after 4 weeks treatment with Thiamine, among patients with primary biliary cholangitis and chronic fatigue;Secondary Objective: Investigate changes in quality of life Investigate side effects to the treatment;Primary end point(s): Reduction in fatigue after 4 weeks treatment with high-dose thiamine;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 Thiamine, among patients with primary biliary cholangitis and chronic fatigue;Secondary Objective: Investigate changes in quality of life Investigate side effects to the treatment;Primary end point(s): Reduction in fatigue after 4 weeks treatment with high-dose thiamine;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 quality of life Side effects;Timepoint(s) of evaluation of this end point: Week 4, 8 and 12	—

Countries

Denmark

Contacts

Public ContactHenning Grønbæk

Aarhus University Hospital

henngroe@rm.dk+4521679281

Outcome results

None listed

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