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
Secondary identifying numbers 226/657
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

Professor James V Parle
Scientific

Department of Primary Care and General Practice
University of Birmingham
Edgbaston
B15 2TT
United Kingdom

Phone +44 (0)121 414 6420
Email j.v.parle@bham.ac.uk

Study information

Study designCommunity based survey and randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeScreening
Scientific title
Study acronymBETS (Birmingham Elderly Thyroid Study)
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedThyroid dysfunction
InterventionIntervention: 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 typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2005
Completion date01/01/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteriaPhase 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 criteriaNot provided at time of registration
Date of first enrolment01/01/2005
Date of final enrolment01/01/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Primary Care and General Practice
Edgbaston
B15 2TT
United Kingdom

Sponsor information

The Health Foundation (UK)
Charity

90 Long Acre
London
WC2E 9RA
United Kingdom

Phone +44 (0)20 7257 8000
Email info@health.org.uk
Website http://www.pppfoundation.org.uk/
ROR logo "ROR" https://ror.org/02bzj4420

Funders

Funder type

Charity

The Health Foundation (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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