Thyroid dysfunction in the elderly: quantifying the association between sub-clinical disease and (i) atrial fibrillation (and thus stroke) (ii) depression and (iii) cognitive dysfunction. A community based survey and clinical trial of thyroxine therapy
| ISRCTN | ISRCTN23090699 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23090699 |
| Protocol serial number | 226/657 |
| Sponsor | The Health Foundation (UK) |
| Funder | The Health Foundation (UK) |
- Submission date
- 12/09/2002
- Registration date
- 12/09/2002
- Last edited
- 14/09/2007
- 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
Prof James V Parle
Scientific
Scientific
Department of Primary Care and General Practice
University of Birmingham
Edgbaston
B15 2TT
United Kingdom
| Phone | +44 (0)121 414 6420 |
|---|---|
| j.v.parle@bham.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Community based survey and randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | BETS (Birmingham Elderly Thyroid Study) |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Thyroid dysfunction |
| Intervention | Intervention: Thyroxine replacement therapy. Dose to be increased by 25 mcg steps during 6 monthly period of monthly monitoring of thyroid function Control: As for intervention group but placebo |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | Phase 1: Aged 65+ Phase 2a: Patients identified in Phase 1 to be suffering from sub-clinical hyperthyroidism Phase 2b: Patients identified in Phase 1 to be suffering from sub-clinical hypothyroidism |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 01/01/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Primary Care and General Practice
Edgbaston
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results for community based survey: | 01/12/2006 | Yes | No |
