Study of optimal replacement of thyroxine in the elderly
| ISRCTN | ISRCTN16043724 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16043724 |
| EudraCT/CTIS number | 2011-004425-27 |
| ClinicalTrials.gov number | NCT01647750 |
| Secondary identifying numbers | 12397 |
- 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
Not provided at time of registration
Contact information
Miss Melinda Jeffels
Scientific
Scientific
4th Floor William Leech Building
Framlington Place
Newcastle Upon Tyne
NE2 4HH
United Kingdom
| melinda.jeffels@newcastle.ac.uk |
Study information
| Study design | Interventional and Observational; Design type: Treatment, Cohort study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Study of Optimal Replacement of Thyroxine in the ElDerly (SORTED) |
| Study 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 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 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 patients willingness to take part in a RCT and participants 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 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Levothyroxine |
| Primary outcome measure | 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 study start date | 01/07/2012 |
| Overall study end date | 30/06/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | Planned Sample Size: 68; UK Sample Size: 68 |
| 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 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
- England
- United Kingdom
Study participating centre
4th Floor William Leech Building
Newcastle Upon Tyne
NE2 4HH
United Kingdom
NE2 4HH
United Kingdom
Sponsor information
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Charity
Charity
Leazes Wing, Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom
"ROR" |
https://ror.org/05p40t847 |
|---|
Funders
Funder type
Government
National Institute for Health Research
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 22/03/2013 | Yes | No | |
| Results article | results | 10/10/2016 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
24/10/2016: Publication reference added.
