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Effect of High‑Dose Thiamine Hydrochloride on Fatigue in Rheumatoid Arthritis Patients: Randomized, Double‑Blind, Placebo‑Controlled Trial

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

In rheumatoid arthritis many individuals report persistent fatigue, a feeling of overwhelming tiredness that is not relieved by rest. The study investigates whether taking a large amount of thiamine (vitamin B1) can lessen this fatigue.

Participants are randomly assigned to receive either tablets containing 1800 mg of thiamine hydrochloride or matching placebo tablets for a period of four weeks. The trial is conducted in a double-blind manner, meaning that neither the participants nor the study staff know which tablets are being taken. Study visits include an initial assessment, regular check‑ins, and a final evaluation after the treatment period.

The purpose is to compare the effect of high dose thiamine with placebo on changes in fatigue as measured by the Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional-Questionnaire global score from the start of the study to week 4.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Baseline assessment
Upon joining the study you complete the initial set of questionnaires, including the braf‑mdq fatigue questionnaire, the braf‑nrs severity, effect and coping scales, and the eq‑5d‑5l health survey. you also undergo a physical examination that records the number of swollen and tender joints (out of 28), a pain rating on a visual analogue scale (0‑100), and a disability assessment using the haq. a blood sample is taken to measure c‑reactive protein levels.
The information collected at this visit serves as the reference point (baseline) for all later comparisons.
Step 2
Randomization and medication receipt
After the baseline visit you are randomly assigned to one of two groups. if assigned to the test group you receive apovit b1 vitamin ekstra stærk tablets; if assigned to the control group you receive matching placebo tablets. the tablets look identical.
Step 3
Medication administration
You take one tablet by mouth each day for a total of four weeks. the test tablet contains thiamine hydrochloride at a dose of 1800 mg per tablet; the placebo tablet contains no active substance. the tablets are taken with water and may be taken at any convenient time of day, but the same time each day is recommended.
Step 4
Daily monitoring
You keep a simple diary noting each dose taken to help ensure that the daily schedule is followed.
Step 5
Four‑week follow‑up visit
At the end of the four‑week treatment period you return for a follow‑up visit. the same set of questionnaires completed at baseline is repeated, including the braf‑mdq, braf‑nrs, and eq‑5d‑5l. the physical examination, joint counts, pain rating, disability assessment, and blood test for c‑reactive protein are performed again.
The data collected at this visit are compared with the baseline values to evaluate any changes.
Step 6
Study completion
After the four‑week visit the study medication is stopped and no further study‑specific procedures are required.

Who can join the trial?

5 criteria

Diagnosed with rheumatoid arthritis – you must have already been told by a doctor that you have this joint disease.
Older than 18 years – you need to be an adult.
Can read and understand Danish and be able to give informed consent – you must understand the study information and agree to take part.
Fatigue score higher than 50 mm on a 100 mm visual analogue fatigue scale – this is a simple line where you mark how tired you feel; a mark above the halfway point (50 mm) shows enough fatigue to join the study.
Willing to use effective contraception during the study – you must agree to use reliable birth‑control methods to prevent pregnancy while taking the study medication.

Who cannot join the trial?

11 criteria

Unable to read, write, or think clearly enough to fill out study questionnaires (illiteracy or cognitive impairment).
Taking more than 10 mg per day of the steroid medication prednisone.
Having abnormal levels of thyroid‑stimulating hormone (TSH), which indicates a thyroid problem.
Having a known allergy to thiamine hydrochloride (a form of vitamin B1).
Having low iron, shown by a ferritin level below 15 µg/L.
Having low folate (vitamin B9), with a level below 9 nmol/L.
Having low vitamin B12, measured as cobalamin below 200 pmol/L.
Having low vitamin D, with a level below 50 nmol/L.
Being pregnant.
Having another serious illness that can cause fatigue, such as cancer, chronic kidney disease, chronic heart failure, or diabetes.
Having changed the treatment for your rheumatoid arthritis or other inflammatory joint disease in the past three months.

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Verified
Odense University Hospital
Odense, Denmark

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Investigated drugs

Thiamine (vitamin B1) is a water‑soluble vitamin that helps the body turn food into energy and supports nerve function. In this study, participants with rheumatoid arthritis took a high‑dose thiamine tablet taken by mouth. The researchers are testing whether giving a larger amount of this vitamin can reduce the fatigue that many people with rheumatoid arthritis experience, compared with a placebo.

Thiamine Hydrochloride

What is already known about the treatment

Placebo (matching Tablets)
The tablets are taken by mouth and contain no active drug, serving only as a control in the study. They are not a medicine and have no therapeutic use in clinical practice. Because they have no active ingredients, they do not act on the body and are classified as an inert substance used for comparison.
APOVIT B1 vitamin ekstra stærk, tabletter 300 mg
This product is an oral tablet that delivers a high dose of thiamine hydrochloride (vitamin B1). Thiamine is a well‑known vitamin that is widely used to treat low thiamine levels and is being studied for fatigue in rheumatoid arthritis. It works by helping the body turn food into energy, supporting nerve and muscle function, and is classified as a water‑soluble vitamin (vitamin B1).

Investigated diseases

Rheumatoid arthritis - It is a long‑lasting condition in which the body’s immune system mistakenly attacks the lining of the joints. The attack causes swelling, warmth, pain and stiffness that are often worse in the morning. Over weeks to months the inflammation can spread to several joints, making movement more difficult. The joint lining may become thickened, leading to loss of normal joint shape. As the disease continues, the affected joints can become less flexible and may produce a feeling of overall tiredness. The pattern of symptoms can vary, with periods of increased activity followed by quieter phases.