Condition category
Nutritional, Metabolic, Endocrine
Date applied
22/06/2012
Date assigned
22/06/2012
Last edited
24/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Melinda Jeffels

ORCID ID

Contact details

4th Floor William Leech Building
Framlington Place
Newcastle Upon Tyne
NE2 4HH
United Kingdom
-
melinda.jeffels@newcastle.ac.uk

Additional identifiers

EudraCT number

2011-004425-27

ClinicalTrials.gov number

NCT01647750

Protocol/serial number

12397

Study information

Scientific title

Study of Optimal Replacement of Thyroxine in the ElDerly (SORTED)

Acronym

SORTED

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.

Ethics approval

12/NE/0098

Study design

Interventional and Observational; Design type: Treatment, Cohort study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

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

Intervention

Patients will be randomised to receive either standard or lower dose dose Levothyroxine

Intervention type

Drug

Phase

Not Applicable

Drug names

Levothyroxine

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

01/07/2012

Overall trial end date

30/06/2013

Reason abandoned

Eligibility

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

Patient

Age group

Senior

Gender

Both

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

01/07/2012

Recruitment end date

30/06/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Sponsor details

Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom

Sponsor type

Charity

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

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

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23522096
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27766119

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

24/10/2016: Publication reference added.