Ongoing, recruitingPhase II and Phase III (Integrated)Interventional

Thiamine against chronic rheumatoid arthritis fatigue

This study, called 'Thiamine against chronic rheumatoid arthritis fatigue,' is investigating whether a high dose of thiamine, also known as vitamin B1, can help manage the severe tiredness (fatigue) often experienced by people with rheumatoid arthritis. Participants will receive either the thiamine treatment or a 'dummy' tablet (placebo) for four weeks. Researchers will then check if there's a meaningful change in their fatigue levels. We're also looking at how the treatment might affect their quality of life and any side effects. This research aims to find better ways to help people living with rheumatoid arthritis feel less tired and improve their daily lives.

At a glance

Status

Ongoing, recruiting

Phase

Phase II and Phase III (Integrated)

Sponsor

Aarhus University Hospital

Enrolment target

Start

20 Oct 2022

Rheumatoid Arthritis

What is this study about?

Many people living with rheumatoid arthritis often experience severe tiredness, or fatigue, which can significantly impact their daily lives. This study is exploring a potential new way to help with this. We are looking at whether taking a high dose of thiamine, which is also known as vitamin B1, can make a difference.

Participants in this study will receive either the thiamine treatment or a tablet that looks exactly the same but doesn't contain any active medicine (this is called a placebo). This helps us accurately compare the effects of thiamine. The main thing we'll be checking is if there's a noticeable change in how tired people feel after four weeks of treatment. We'll be using special questionnaires to measure this.

Beyond just fatigue, we are also interested in how this treatment might affect a person's general quality of life. We'll also be monitoring for any side effects, as safety is always a top priority. The goal of this research is to discover if thiamine could be a helpful and safe option for reducing fatigue in those with rheumatoid arthritis.

Key takeaways

This study explores if high-dose vitamin B1 (thiamine) can reduce fatigue in rheumatoid arthritis.
Participants will receive either thiamine or a dummy tablet (placebo).
The main goal is to measure changes in fatigue after four weeks of treatment.
Researchers will also check quality of life and any side effects.
The study aims to find new ways to help manage RA-related tiredness.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. Both men and women are welcome to take part. The study is specifically for people who have been diagnosed with rheumatoid arthritis.

Beyond your age and your rheumatoid arthritis diagnosis, the medical team will review other aspects of your health to make sure the study is a good fit for you. This is to ensure your safety and that the study results are as clear as possible. They will check if you meet all the specific requirements needed for the research.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of rheumatoid arthritis?
Are you a man or a woman?
Have you spoken to your doctor about your general health?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given either the thiamine tablets or a harmless dummy tablet (placebo) to take. These tablets are white, round, and have a line on one side. You'll take these for four weeks.

During the study, you'll have specific appointments where the research team will check your fatigue levels using questionnaires. They will also assess your general quality of life and take blood samples to check your lactate levels – this is a substance in your blood that can be linked to energy. These checks will happen at the start, after 4 weeks of treatment, and then again at 8 and 12 weeks to see how you are doing over time. The team will also keep a close eye on any side effects you might experience. The total duration of your active involvement will be around 12 weeks.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, such as the possibility of reducing your fatigue levels if you receive the active thiamine treatment. You will also receive careful medical monitoring throughout the study. However, there's always a chance you might receive the placebo, meaning you wouldn’t get the active treatment. As with any medication, there's a potential for side effects, which will be carefully monitored by the research team. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Denmark

Common questions

What is thiamine?

Thiamine is also known as vitamin B1. It's an important vitamin that your body uses for energy and nerve function.

Will I know if I'm getting thiamine or a placebo?

No, during the study, neither you nor the study team will know whether you are receiving thiamine or the placebo. This helps make the study results more reliable.

What is 'fatigue' in this study?

Fatigue here refers to the severe, persistent tiredness often experienced by people with rheumatoid arthritis, which doesn't get better with rest.

How long will the study last?

Each participant will be involved for about 12 weeks, including four weeks of taking the tablets and follow-up checks.

What does 'quality of life' mean in this study?

It means how the treatment might affect your general well-being, including your physical and emotional health, and your ability to do daily activities.