Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Miss Melinda Jeffels


Contact details

4th Floor William Leech Building
Framlington Place
Newcastle Upon Tyne
United Kingdom

Additional identifiers

EudraCT number

2011-004425-27 number


Protocol/serial number


Study information

Scientific title



Study hypothesis

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 patient’s 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 heartbeat.

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.

More details can be found at

Ethics approval


Study design

Interventional and Observational; Design type: Treatment, Cohort study

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet


Topic: Primary Care Research Network for England, Metabolic and Endocrine; Subtopic: Not Assigned, Metabolic and Endocrine (all Subtopics); Disease: Metabolic & Endocrine (not diabetes), All Diseases


Levothyroxine (for SORTED 1), Patients will be randomised to receive either standard or lower dose dose Levothyroxine

Intervention type



Not Applicable

Drug names


Primary outcome measures

Patients willingess to participate and acceptability of study design; Timepoint(s): For the duration of the SORTED 1 study

Secondary outcome measures

1. Assessment of change in specific cardiovascular risk factors
2. Assessment of dose titration strategy
3. Assessment of length of time to achieve desired TSH level
4. Assessment of mobility and risk of falls in this population group
5. Assessment of participant recruitment rate; Timepoint(s): Over the duration of the SORTED 1 study, until last patient is randomised; Assessment of 6. Use of quality of life questionnaires

Assessed over the duration of the SORTED 1 study

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Males and females aged 80 years or older
2. Diagnosed with hypothyroidism and treated with LT4 for at least 6 months
3. Living independently in the community
4. All TSH results within the range 0.4 - 4mU/L in the 3 months before commencing the study
5. Participant has provided written informed consent for participation in the study, prior to any study-specific procedures.

Participant type


Age group




Target number of participants

Planned Sample Size: 68; UK Sample Size: 68

Participant exclusion criteria

1. Established dementia and therefore deemed incapable of providing informed consent.
2. Other medical conditions which, in the opinion of the Chief Investigator, would prevent them from participating in the study (for example, end stage cancer, severe chronic health conditions where the patient is housebound)
3. Nursing Homes or Residential Care Home residents
4. Individuals with thyroid cancer: since they require high doses of LT4 to suppress their serum TSH
6. Individuals on 25 mcg daily of LT4: dose reduction will mean that they stop thyroid replacement treatment
7. Non English speaking individuals
8. Participation in any other investigational trials within the last 3 months
9. Participants prescribed medications that can affect thyroid function (amiodarone, lithium, carbimazole or propylthiouracil)
10. Known or suspected lactose intolerance (this would have implications for the proposed over-encapsulated IMP)

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

4th Floor William Leech Building
Newcastle Upon Tyne
United Kingdom

Sponsor information


Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Sponsor details

Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
United Kingdom

Sponsor type




Funder type


Funder name

National Institute for Health Research (NIHR (UK) - Research for Patient Benefit Programme

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2013 protocol in

Publication citations

  1. Protocol

    Wilkes S, Pearce S, Ryan V, Rapley T, Ingoe L, Razvi S, Study of Optimal Replacement of Thyroxine in the ElDerly (SORTED): protocol for a mixed methods feasibility study to assess the clinical utility of lower dose thyroxine in elderly hypothyroid patients: study protocol for a randomized controlled trial., Trials, 2013, 14, 83, doi: 10.1186/1745-6215-14-83.

Additional files

Editorial Notes