Rheumatoid Arthritis
Conditions
Brief summary
A change in fatigue level immediately after 4 weeks of high-dose thiamine treatment. The minimal clinically important difference (MCID) is a decrease of 7,43 points or an increase of 2,58 points on the BRAF-MDQ total fatigue score.
Detailed description
A change in the patients’ quality of life at week 4, 8 and 12. Difference in EQ-5D score, MCID of 0,04., A change in blood lactate concentration at week 4, 8 and 12., Side effects to the treatment.
Interventions
DRUGTHIAMINE (VIT B1)
DRUGPlacebo (Lactose monohydrate
DRUGpotato starch
DRUGgelatin A
DRUGwater purified
DRUGmagnesium stearate MF 2V
DRUGTalc.)
12 mm
DRUGwhite
DRUGround
DRUGplane tablets with slanted edges
DRUGscoreline on one side.
Identical formulation to the SAD tablet
DRUGbut without the active ingredient.
Sponsors
Aarhus University Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A change in fatigue level immediately after 4 weeks of high-dose thiamine treatment. The minimal clinically important difference (MCID) is a decrease of 7,43 points or an increase of 2,58 points on the BRAF-MDQ total fatigue score. | — |
Secondary
| Measure | Time frame |
|---|---|
| A change in the patients’ quality of life at week 4, 8 and 12. Difference in EQ-5D score, MCID of 0,04., A change in blood lactate concentration at week 4, 8 and 12., Side effects to the treatment. | — |
Countries
Denmark
Outcome results
None listed