SORTED

• Research type

  Research Study

• Full title

  Study of Optimal Replacement of Thyroxine in the ElDerly (SORTED) SORTED 1 – a Randomised Controlled Trial (Pilot study) SORTED 2 – Qualitative Interviews SORTED 3 – Retrospective Cohort

• IRAS ID

  93176

• Contact name

  Salman Razvi

• Sponsor organisation

  Newcastle Upon Tyne Hospital

• Eudract number

  2011-004425-27

• ISRCTN Number

  N/A

• Research summary

  All patients with hypothyroidism are currently treated the same way, regardless of age. We want to look at whether people aged 80 years or older would benefit from being treated with lower doses of levothyroxine. There are three reasons why we think this could be beneficial, but this is not yet proven: 1. Some older people with hypothyroidism may have few symptoms. 2. Doctors look at the amount of Thyroid Stimulating Hormone (TSH) in the patients?? blood to decide the dose of Thyroxine received. The standard ??normal? TSH range used to determine the dose of levothyroxine is from younger people. We wonder whether this is appropriate to all age ranges particularly as we know that older people may normally have higher TSH values. 3. If TSH levels are too low there may be a slight increased risk of problems such as brittle bones or an irregular heart-beat. The best way to test whether older people benefit from lower doses of levothyroxine is by a large clinical trial. Before we can do this, we need to run a smaller clinical trial called a ??pilot study? (SORTED 1) to examine whether this is practical and acceptable. The pilot study aims to recruit 50 patients with hypothyroidism aged 80 or above. Participants will be randomly allocated to receive their routine or lower dose of levothyroxine. Follow-up will be conducted over approximately 25 weeks. We also propose a qualitative study (SORTED 2) to specifically understand patient??s willingness to take part in a RCT and participant's experience of the intervention. Finally, we propose a retrospective cohort study of 400 treated hypothyroid patients aged 80 years or more registered in 2008 in Primary Care Practices with the aim of studying outcomes after 4 years. The cohort study will collect data required to inform a sample size calculation for a future full study where the primary outcome will be 4 year mortality.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  12/NE/0098

• Date of REC Opinion

  3 Apr 2012

• REC opinion

  Favourable Opinion