2024-519268-41-00Not yet recruitingPhase 4
BEAT Fatigue
BEAT Fatigue – Benefit of Elevated Administration of Thiamine for Fatigue in Rheumatoid Arthritis: A randomized, double-blind, placebo-controlled trial
Source: EU CTIS (euclinicaltrials.eu) · Last updated 12 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 5 Jan 2026
- Start date
- 1 Jul 2026
- Lead sponsor
- Odense University Hospital
- Diseases
- Rheumatoid arthritis
- EU CT number
- 2024-519268-41-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 150
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients treated with doses of prednisone exceeding 10 mg/day.
Other illness
- 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.
Lab values
- Iron deficiency (Ferritin < 15 µg/L)
Other
- TSH abnormalities
- Folate acid deficiency (< 9 nmol/L)
- Vitamin B12 deficiency (cobalamin < 200 ρmol/L)
- Vitamin D deficiency (< 50 nmol/L)
- Pregnant women
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Esbjerg Og Grindsted Sygehus | Esbjerg | Denmark | Not yet recruiting |
| Odense University Hospital | Odense C | Denmark | Not yet recruiting |
| Slagelse Hospital | Slagelse | Denmark | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.