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.
Phase:
Phase 4
Details
Lead Sponsor:
Henning Grønbæk
Collaborators:
Aarhus University Hospital GCP-unit at Aarhus University Hospital, Aarhus, Denmark Hospitalsapoteket Region Midtjylland Region Hovedstadens Apotek