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ISRCTN
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ISRCTN23090699
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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BETS (Birmingham Elderly Thyroid Study)
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Serial number at source
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226/657
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Study hypothesis
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Not provided at time of registration
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Community based survey and randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Thyroid dysfunction
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/01/2005
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Anticipated end date
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01/01/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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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
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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The Health Foundation (UK)
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Trial website
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Publications
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Results for community based survey: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=17003083
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Contact name
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Professor
James V
Parle
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Address
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Department of Primary Care and General Practice
University of Birmingham
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City/town
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Edgbaston
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Zip/Postcode
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B15 2TT
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Country
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United Kingdom
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Tel
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+44 (0)121 414 6420
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Fax
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+44 (0)121 414 7938
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Email
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j.v.parle@bham.ac.uk
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Sponsor
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The Health Foundation (UK)
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Address
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90 Long Acre
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City/town
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London
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Zip/Postcode
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WC2E 9RA
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Country
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United Kingdom
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Tel
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+44 (0)20 7257 8000
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Fax
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+44 (0)20 7257 8001
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Email
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info@health.org.uk
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Sponsor website:
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http://www.pppfoundation.org.uk/
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Date applied
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12/09/2002
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Last edited
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14/09/2007
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Date ISRCTN assigned
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12/09/2002
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