PBC Induced Fatigue Treated With Thiamine

Primary Biliary Cirrhosis Clinical Trial

— PIFT  

Official title:

PBC Induced Fatigue Treated With Thiamine (PIFT) - The Effect of Oral Thiamine Supplement in 4 Weeks to Patients With Primary Biliary Cholangitis (PBC) and Chronic Fatigue. A Randomised Placebo Controlled Crossover Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04893993
• Other study ID #: PIFT AU
• Status: Recruiting
• Phase: Phase 4
• Start date: May 12, 2021
• Est. completion date: December 2023

Study information

• Verified date: May 2021
• Source: University of Aarhus
• Contact: Henning Grønbæk, Professor
• Phone: +45 21679281
• Email: henngroe[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Primary biliary cholangitis (PBC) is a chronic autoimmune liver disease characterised by destruction of the intrahepatic bile ducts leading to liver inflammation and fibrosis, and ultimately liver cirrhosis and end-stage liver disease. More than 50% of patients with PBC suffer from chronic fatigue, and approximately 20% suffer from severe fatigue with negative impact on their quality of life. Although fatigue is a large problem in patients with PBC, no effective treatments are available. A Danish intervention study have shown that high dose oral thiamine (Vitamin B1) were effective in treating chronic fatigue in patients with inflammatory bowel disease. In this study, only few and minor adverse events to thiamine treatment were observed. Although the precise mechanism of work remains unknown, the investigators see no reason that this cannot be transferred topatients with PBC. Hence, the investigators aim to conduct a study investigating the use of oral thiamine in chronic fatigued patients with PBC. The study will be conducted as a double-blinded, placebo-controlled, randomised, crossover trial including 36 patients with PBC and with a higher fatigue level than in the general population for more than six months. The patients will be randomised into one of two 3x4 weeks setups; 1) thiamine for four weeks followed by four weeks washout and finally four weeks of placebo or 2) placebo for four weeks followed by four weeks washout and finally four weeks of thiamine. The primary endpoint is to investigate the fatigue-level before and after treatment with thiamine and placebo using every patient as their own control. Fatigue-level will be measured using international validated questionnaires. The doses of thiamine are calculated based on the patient gender and weight. All patients will be included in the outpatient clinic at the Department of Hepatology and Gastroenterology at Aarhus University Hospital.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• PBC for more than 3 months
• PBC-40 fatigue score >32
• Fatigued for at least 6 months

Exclusion Criteria:

• Comorbidity that can explain fatigue
• Non-compliant patients
• Pregnancy
• Expected surgical interventions during the study period
• Chronic kidney disease (eGFR<60)

Related Conditions & MeSH terms

• Fatigue
• Liver Cirrhosis, Biliary
• Primary Biliary Cirrhosis

Intervention

Drug:
• Thiamine
Tablets. 300mg/tablet. Dosage depends on gender and weight
• Placebo
Tablets. Same number of tablets as Thiamine

Locations

Country	Name	City	State
Denmark	Department of Hepatology and Gastroenterology, Aarhus University Hospital, Denmark	Aarhus N	Region Midtjylland

Sponsors (5)

Lead Sponsor	Collaborator
Henning Grønbæk	Aarhus University Hospital, GCP-unit at Aarhus University Hospital, Aarhus, Denmark, Hospitalsapoteket Region Midtjylland, Region Hovedstadens Apotek

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue	Change in levels of fatigue measured by the Primary biliary cholangitis-40 (PBC-40) fatigue domain. The fatigue domain measures the severity of fatigue on a scale from 11-55, where 55 is maximun fatigue. A change in PBC-40 fatigue domain of 5 points or more is regarded as a clinical relevant change.	After 4 weeks active treatment
Secondary	Disease-specific Quality of Life	Changes in Health-related Quality of life, measured by the disease specific Primary biliary Cholangitis-40 (PBC-40).	Week 4, 8 and 12
Secondary	Health-related Quality of Life	Changes in Health-related Quality of Life, measured by the generic EQ-5D-5L tool (mainly the VAS-scale from 0-100, where 100 is best).	Week 4, 8 and 12
Secondary	Fatigue	Change in levels of fatigue measured by the Primary biliary cholangitis-40 (PBC-40) fatigue domain. The fatigue domain measures the severity of fatigue on a scale from 11-55, where 55 is maximun fatigue. A change in PBC-40 fatigue domain of 5 points or more is regarded as a clinical relevant change.	Week 8 and 12