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Study on Thiamine for Reducing Fatigue in Rheumatoid Arthritis Patients

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What is this trial about?

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

This clinical trial is focused on studying the effects of high-dose oral thiamine, also known as Vitamin B1, on reducing chronic fatigue in patients with rheumatoid arthritis. Rheumatoid arthritis is a long-term condition that causes pain, swelling, and stiffness in the joints. Many people with this condition also experience chronic fatigue, which is a persistent feeling of tiredness that doesn't improve with rest.

The purpose of the study is to see if taking thiamine for four weeks can help reduce this fatigue. Participants in the study will either receive thiamine or a placebo, which looks like the thiamine tablet but does not contain the active ingredient. The study will last for a total of four weeks, during which participants will take the medication daily. The main focus is to observe any changes in fatigue levels after the treatment period.

Throughout the study, participants' quality of life and blood lactate levels will also be monitored at different intervals, specifically at weeks 4, 8, and 12. Blood lactate is a substance that can indicate how the body is using energy. Additionally, any side effects from the treatment will be recorded to ensure the safety and well-being of the participants. This study aims to provide valuable insights into whether thiamine can be an effective treatment for fatigue in those living with rheumatoid arthritis.

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
Joining the study
Upon joining the study, you will be asked to sign an informed consent form. This document confirms your understanding of the study and your agreement to participate.
You must meet certain criteria to participate, including having been diagnosed with rheumatoid arthritis for more than 3 months, experiencing chronic fatigue for at least 6 months, and being 18 years or older.
Step 2
Initial assessment
An initial assessment will be conducted to evaluate your current fatigue levels using the Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire (BRAF-MDQ).
Your quality of life and blood lactate concentration will also be measured.
Step 3
Medication administration
You will receive either a high dose of thiamine (vitamin B1) or a placebo. The placebo is a tablet that looks like the thiamine tablet but does not contain the active ingredient.
The medication is taken orally for a duration of 4 weeks. The exact dosage and frequency will be provided by the study team.
Step 4
Follow-up assessments
After 4 weeks of treatment, your fatigue levels will be reassessed using the BRAF-MDQ.
Additional assessments of your quality of life and blood lactate concentration will be conducted at weeks 4, 8, and 12.
Step 5
Monitoring side effects
Throughout the study, any side effects you experience will be monitored and recorded.
It is important to report any changes in your health to the study team promptly.
Step 6
Completion of the study
At the end of the study, a final assessment will be conducted to evaluate the overall impact of the treatment on your fatigue and quality of life.
The study team will provide you with information on the results and any next steps.

Who can join the trial?

13 criteria

Must have been diagnosed with Rheumatoid Arthritis more than 3 months ago.
Must have the disease under control or with mild activity, which means:
- CRP (a blood test that measures inflammation) less than 10 mg/l.
- MD-HAQ (a questionnaire about health) score less than 1.3.
- DAS28 (a measure of disease activity) score less than 3.2.
- Must experience chronic fatigue (feeling very tired) for at least 6 months, with a fatigue score of 16 or higher on the BRAF questionnaire.
- Must be 18 years of age or older.
- Must sign an informed consent form, which means agreeing to participate after understanding the study.
- If able to become pregnant, must use a safe anticontraceptive method during the trial (12 weeks). Safe methods include:
  - Combination pills
  - Intrauterine device (IUD)
  - Depot injection
  - Subdermal implant
  - Hormonal vaginal ring
  - Transdermal depot patch

Who cannot join the trial?

4 criteria

Patients who do not have Rheumatoid Arthritis cannot participate.
Patients who are not experiencing chronic fatigue cannot participate. Chronic fatigue means feeling extremely tired for a long time.
Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important to check if you fit the required age group.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups like pregnant women, children, or people who cannot make decisions for themselves.

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Region Midtjylland
Responsive
Aarhus, Denmark

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Investigated drugs

Thiamine is a type of vitamin, also known as vitamin B1, that is being tested in this study to see if it can help reduce fatigue in people with rheumatoid arthritis. Fatigue is a common problem for people with this condition, and the study is looking at whether taking thiamine for four weeks can make a difference in how tired people feel. The goal is to see if thiamine can improve energy levels and help people feel less exhausted in their daily lives.

Benfotiamine

What is already known about the treatment

Thiamine – Thiamine is administered orally in the form of tablets and is currently being studied for its potential benefits in treating chronic fatigue associated with rheumatoid arthritis. This vitamin, also known as Vitamin B1, is being explored in medical research to see if high doses can help reduce fatigue in these patients. Thiamine works by helping the body convert food into energy, which is crucial for maintaining energy levels. It is classified as a vitamin and is generally known for its role in supporting energy metabolism and nerve function.

Investigated diseases

Rheumatoid Arthritis – Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects the joints. It occurs when the immune system mistakenly attacks the body's own tissues, leading to inflammation. Over time, this inflammation can cause damage to the cartilage and bones within the joint. The disease often starts in smaller joints, such as those in the fingers and toes, and can progress to larger joints like the wrists, knees, and ankles. As the condition advances, it can lead to joint deformity and loss of function. In addition to joint issues, rheumatoid arthritis can also affect other systems in the body, causing symptoms like fatigue and general malaise.