Study of optimal replacement of thyroxine in the elderly

Not Applicable

Completed

Conditions: 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
Nutritional, Metabolic, Endocrine
Hypothyroidism, unspecified

Registration Number: ISRCTN16043724

Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 68

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

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
1. Assessment of change in specific cardiovascular risk factors<br>2. Assessment of dose titration strategy<br>3. Assessment of length of time to achieve desired TSH level<br>4. Assessment of mobility and risk of falls in this population group<br>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<br><br>Assessed over the duration of the SORTED 1 study