Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/09/2002
Date assigned
12/09/2002
Last edited
14/09/2007
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

Professor James V Parle

ORCID ID

Contact details

Department of Primary Care and General Practice
University of Birmingham
Edgbaston
B15 2TT
United Kingdom
+44 (0)121 414 6420
j.v.parle@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

226/657

Study information

Scientific title

Acronym

BETS (Birmingham Elderly Thyroid Study)

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Community based survey and randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Screening

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2005

Overall trial end date

01/01/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2005

Recruitment end date

01/01/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

The Health Foundation (UK)

Sponsor details

90 Long Acre
London
WC2E 9RA
United Kingdom
+44 (0)20 7257 8000
info@health.org.uk

Sponsor type

Charity

Website

http://www.pppfoundation.org.uk/

Funders

Funder type

Charity

Funder name

The Health Foundation (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results for community based survey: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=17003083

Publication citations

  1. Results for community based survey

    Wilson S, Parle JV, Roberts LM, Roalfe AK, Hobbs FD, Clark P, Sheppard MC, Gammage MD, Pattison HM, Franklyn JA, , Prevalence of subclinical thyroid dysfunction and its relation to socioeconomic deprivation in the elderly: a community-based cross-sectional survey., J. Clin. Endocrinol. Metab., 2006, 91, 12, 4809-4816, doi: 10.1210/jc.2006-1557.

Additional files

Editorial Notes