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Contact Information:

Prof Simon Pearce
+44 (0)1912418674
simon.pearce@ncl.ac.uk


Study Location:

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Be Part of Research - Trial Details - Optimal prescribing of levothyroxine for underactive thyroid gland treatment

Optimal prescribing of levothyroxine for underactive thyroid gland treatment

Recruiting

Open to: All Genders

Age: Adult

Medical Conditions

Hypothyroidism


This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.


Levothyroxine is the third most commonly prescribed medication in the UK and at 4 pence per 100-μg tablet is amongst the cheapest. The general assumption has been that when patients are prescribed levothyroxine for a diagnosis of hypothyroidism (thyroid underactivity), the treatment is life-long. However, the commonest cause of hypothyroidism is Hashimoto’s (autoimmune) thyroiditis, which may result in a variable degree of mild hypothyroidism or even have a relapsing/remitting course in some patients. In addition, levels in the blood of thyroid stimulating hormone (TSH) may rise for a short period following any ‘non-thyroidal illness’ and this physiological phenomenon may easily be mistaken for mild hypothyroidism in someone who doesn’t feel well following an intercurrent infection or other health issues. Therefore, guidelines suggest observing such patients for 3 to 6 months to see if the elevation of TSH is persistent and then considering a trial of levothyroxine treatment in younger patients with compatible hypothyroid symptoms. Unfortunately, not all short-duration, variable or mild hypothyroidism is recognised as such, leading to overtreatment.

Recent evidence both from the US and the UK suggests that many patients with only mildly abnormal or even normal thyroid blood tests are being prescribed levothyroxine in primary care settings. A complementary meta-analysis of 11 studies showed that if levothyroxine therapy is withdrawn, 30-50% of patients remain euthyroid (with normal TSH levels). Thus, overprescribing levothyroxine is a potentially detrimental situation, not only because of wasted resources in medication prescriptions and monitoring blood tests but also because out-of-range thyroid tests are found in around 50% of people taking levothyroxine, which are associated with several undesirable health outcomes, including fractures, heart problems and increased mortality. Because levothyroxine is taken by around 3 million people in the UK, overprescribing could be adversely affecting the health of around half a million people. This study aims to address how this important public health issue can be best addressed.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

20 Jun 2022 01 Nov 2024

Patients will be asked to temporarily stop taking their levothyroxine for 6 weeks. Thyroid blood tests will be done at the end of 6 weeks and quality of life will be measured at the start and end of the study. Patients will be asked what they thought about stopping their medication, how they felt during the period off levothyroxine and whether they would recommend trying off thyroid medications to a friend. After 6 weeks, patients will have the option of staying on medication if they prefer, but if their thyroid tests are suitable, they will be offered the chance to remain off levothyroxine.


Patients identified from GP databases as taking levothyroxine for more than 6 months

You can take part if:



You may not be able to take part if:


Does not meet the inclusion criteria


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Forest Hall Medical Group
    Station Road Forest Hall
    Newcastle upon Tyne
    NE12 9BQ

Benefits and risks not provided at time of registration


The study is sponsored by Newcastle upon Tyne Hospitals NHS Foundation Trust and funded by Newcastle University.




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Read full details for Trial ID: ISRCTN65030272

Or CPMS 52796

Last updated 08 November 2023

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