Trial of mycophenolate for persistent symptoms of hypothyroidism
The TRIUMPH trial is investigating if a medicine called mycophenolate mofetil can help women aged 18 to 50 who have an underactive thyroid (Hashimoto's Thyroiditis) but still suffer from symptoms like feeling tired, heavy, having problems with their weight, aches, pains, and 'brain fog'. Researchers think that ongoing swelling (inflammation) in the thyroid gland might be causing these issues. This study aims to see if mycophenolate mofetil can reduce this inflammation and improve how people feel. Participants will either receive the study drug or a dummy pill for four months, without knowing which they're getting. Mycophenolate has been used safely for many years for other conditions.
At a glance
What is this study about?
The TRIUMPH trial is a research study looking at a new way to help women who have an underactive thyroid, specifically a condition called Hashimoto's Thyroiditis. Even though many women with this condition take medicine for their thyroid, some still experience troubling symptoms like feeling very tired, sluggish, struggling with their weight, having aches and pains, and feeling like their brain isn't working clearly (often called 'brain fog').
Researchers believe that these ongoing symptoms might be caused by continuous swelling or irritation (inflammation) in the thyroid gland itself. The main goal of this study is to find out if a drug called mycophenolate mofetil can help reduce this inflammation. If it can, the hope is that it will also help reduce these bothersome symptoms and make women feel better overall.
Mycophenolate mofetil is not a new drug; it has been used safely for over 25 years to treat various conditions where the body's immune system mistakenly attacks its own tissues, such as arthritis and certain liver problems. However, this is the first time it's being tested specifically for Hashimoto's Thyroiditis, making this an important study.
Key takeaways
- The study is for women aged 18-50 with Hashimoto's and ongoing symptoms.
- It aims to see if mycophenolate can reduce thyroid inflammation and improve symptoms.
- Participants will get either the drug or a dummy pill for four months.
- Mycophenolate has been used safely for other conditions for over 25 years.
- The study is based in Newcastle upon Tyne and funded by the Medical Research Council.
Who may be eligible?
This study is looking for women aged between 18 and 50 years who have Hashimoto's Thyroiditis, which is a common cause of an underactive thyroid. To join, your thyroid hormone levels (specifically TSH) must currently be within the normal range, meaning your usual thyroid medication is working to keep them balanced, and you must have been on a stable dose for at least three months. You also need to have specific antibodies in your blood that confirm Hashimoto's.
Crucially, you must still be experiencing significant tiredness. There are certain health conditions that would prevent you from taking part, such as some types of liver or kidney problems, severe anaemia, or other significant ongoing health issues that might explain your symptoms. If you are pregnant, breastfeeding, or planning a pregnancy within six months, you cannot participate. You also need to be willing to use effective contraception if you could become pregnant during the study. Finally, you cannot be taking certain medications that would interact with the study drug.
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 a woman aged between 18 and 50 years old?
- Do you have a diagnosis of Hashimoto's Thyroiditis (underactive thyroid)?
- Are your thyroid hormone levels currently normal because of your usual medication?
- Have you been on a stable dose of your thyroid medication for at least 3 months?
- Do you still experience persistent and bothersome tiredness despite your current treatment?
- Are you not pregnant, breastfeeding, or planning to get pregnant in the next 6 months?
What does participation involve?
If you decide to take part in the study, you will be randomly placed into one of two groups. Many participants (30 people) will receive the study drug, mycophenolate mofetil, and a smaller number (18 people) will receive a placebo, which is a 'dummy' pill with no active ingredient. Neither you nor your doctors will know which treatment you are receiving until the study is finished. You will take one tablet twice a day for a period of four months.
Throughout the study, you will have several appointments to check your health, symptoms, and how you are responding to the treatment. This will involve blood tests and possibly other assessments. The study is run by the Newcastle upon Tyne Hospitals NHS Foundation Trust in the UK. The entire study is expected to run from May 2025 to April 2028, but your individual participation would only be for the four months of treatment and any follow-up visits.
Potential risks and benefits
Locations (1)
- Royal Victoria InfirmaryApproximateNewcastle upon Tyne, United Kingdom
Common questions
What is Hashimoto's Thyroiditis?
It's a condition where your body's immune system mistakenly attacks your thyroid gland, leading to an underactive thyroid.
What is mycophenolate mofetil?
It's a medicine often used to calm down the immune system in conditions like arthritis. This study is exploring if it can help with Hashimoto's.
Will I know if I'm getting the real drug or a dummy pill?
No, it's a 'blinded' study, meaning neither you nor your doctor will know until the trial finishes.
How long will I take the study drug for?
You will take the tablets twice a day for four months.
What if I change my mind after joining?
You can withdraw from the study at any time without having to give a reason, and it won't affect your regular medical care.
How to find out more
. Study Team
Always speak to your GP or specialist before deciding to take part in a study.
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