Study of optimal replacement of thyroxine in the elderly

ISRCTN ISRCTN16043724
DOI https://doi.org/10.1186/ISRCTN16043724
ClinicalTrials.gov (NCT) NCT01647750
Clinical Trials Information System (CTIS) 2011-004425-27
Protocol serial number 12397
Sponsor Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Funder National Institute for Health Research
Submission date
22/06/2012
Registration date
22/06/2012
Last edited
24/10/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Melinda Jeffels
Scientific

4th Floor William Leech Building
Framlington Place
Newcastle Upon Tyne
NE2 4HH
United Kingdom

melinda.jeffels@newcastle.ac.uk

Study information

Primary study designInterventional
Study designInterventional and Observational; Design type: Treatment, Cohort study
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleStudy of Optimal Replacement of Thyroxine in the ElDerly (SORTED)
Study acronymSORTED
Study objectivesAll 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.
Ethics approval(s)12/NE/0098
Health condition(s) or problem(s) studiedTopic: Primary Care Research Network for England, Metabolic and Endocrine; Subtopic: Not Assigned, Metabolic and Endocrine (all Subtopics); Disease: Metabolic & Endocrine (not diabetes), All Diseases
InterventionPatients will be randomised to receive either standard or lower dose dose Levothyroxine
Intervention typeDrug
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Levothyroxine
Primary outcome measure(s)

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

Key secondary outcome measure(s)

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

Completion date30/06/2013

Eligibility

Participant type(s)Patient
Age groupSenior
SexAll
Target sample size at registration68
Key inclusion criteria1. 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
Key exclusion criteria1. 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)
Date of first enrolment01/07/2012
Date of final enrolment30/06/2013

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

4th Floor William Leech Building
Newcastle Upon Tyne
NE2 4HH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 10/10/2016 Yes No
Protocol article protocol 22/03/2013 Yes No
HRA research summary 28/06/2023 No No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

24/10/2016: Publication reference added.

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