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Not yet taking people in DenmarkPhase 4

Tests thiamine for fatigue in people with rheumatoid arthritis

Tests high-dose thiamine against a placebo in adults with rheumatoid arthritis and fatigue.

Key facts

Who runs it
Odense University Hospital
Where
Esbjerg, Odense C, and Slagelse, DenmarkSee the 3 sites
Registry title
BEAT Fatigue
Status
Not yet recruiting
Phase
Phase 4
People taking part
150 people, planned
Started
1 Jul 2026
Expected to end
31 Dec 2026
Type of study
Interventional
Record updated
12 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with rheumatoid arthritis who have a lot of fatigue. It compares high dose thiamine with a placebo.

Age
Older than 18 years.
Sex
All sexes can join.
Disease stage
Established rheumatoid arthritis with fatigue scoring above 50 mm on a 100 mm visual analogue fatigue scale.
Earlier treatment
Treatment of the rheumatic disease must not have been changed within the last 3 months. Prednisone must not be above 10 mg/day.
Biomarker or test result
No abnormal TSH. No iron deficiency (ferritin below 15 µg/L), folate deficiency (below 9 nmol/L), vitamin B12 deficiency (below 200 ρmol/L) or vitamin D deficiency (below 50 nmol/L).

Main reasons for not taking part

  • Cannot complete the questionnaires because of illiteracy or cognitive impairment
  • Known allergy to Thiaminhydrochlorid
  • Pregnant women
  • Other illness that can explain high fatigue, such as cancer, chronic kidney disease, chronic heart failure or diabetes
  • Prednisone above 10 mg/day

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • Patients with an established diagnose of rheumatoid arthritis
  • > 18 years of age
  • Able to read and understand Danish and give informed consent
  • Score of > 50 mm on a 100 mm visual analogue fatigue scale
  • Willingness to ensure effective contraception during the study period

Who cannot take part

  • Patients treated with doses of prednisone exceeding 10 mg/day
  • Patients who by virtue of illiteracy or cognitive impairment are unable to complete the questionnaires
  • Known allergic reaction to Thiaminhydrochlorid
  • Co-morbidity that can explain high levels of fatigue including cancer, chronic kidney disease, chronic heart failure, diabetes
  • Modification of treatment of the inflammatory rheumatic disease within 3 months
  • Iron deficiency (Ferritin < 15 µg/L)
  • TSH abnormalities
  • Folate acid deficiency (< 9 nmol/L)
  • Vitamin B12 deficiency (cobalamin < 200 ρmol/L)
  • Vitamin D deficiency (< 50 nmol/L)
  • Pregnant women

Where in Denmark

  • Esbjerg Og Grindsted SygehusEsbjerg, DenmarkNot yet recruiting
  • Odense University HospitalOdense C, DenmarkNot yet recruiting
  • Slagelse HospitalSlagelse, DenmarkNot yet recruiting

About the trial

What the trial wants to find out

The primary objective is to compare the effect of High Dose Tiamine (HDT,) relative to placebo, on the change from baseline to 4 weeks in the Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional-Questionnaire global (BRAF-MDQ-global) (16), among patients diagnosed with RA suffering from fatigue.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
BEAT Fatigue – Benefit of Elevated Administration of Thiamine for Fatigue in Rheumatoid Arthritis: A randomized, double-blind, placebo-controlled trial
Plain-language title
Tests thiamine for fatigue in people with rheumatoid arthritisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
12 June 2026