Cross-over randomised trial of adult hypothyroidism screening

ISRCTN ISRCTN00049084
DOI https://doi.org/10.1186/ISRCTN00049084
Secondary identifying numbers CTHS02
Submission date
29/01/2009
Registration date
10/02/2009
Last edited
09/11/2011
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 Malcolm Law
Scientific

Wolfson Institute of Preventive Medicine
Queen Mary University of London
Charterhouse Square
London
EC1M 6BQ
United Kingdom

Study information

Study designSingle centre double-blind randomised cross-over trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Can be found at: http://www.wolfson.qmul.ac.uk/hssleaflet/hssleaflet.pdf
Scientific titleA double blind randomised cross-over trial to assess the value of screening an adult population for hypothyroidism
Study acronymHSS
Study objectivesPeople detected with high thyroid stimulating hormone (TSH) through general screening respond symptomatically to thyroxine.
Ethics approval(s)Oxfordshire Research Ethics Committee A gave approval on the 7th June 2005 (ref: 05/Q1604/67)
Health condition(s) or problem(s) studiedPrimary hypothyroidism
InterventionEach participant was allocated in random sequence to take thyroxine and placebo capsules, each for four months. During the thyroxine phase, participants started at a daily dose of 50 µg and this dose was increased by 25 µg per month until the serum TSH concentration fell below a pre-specified value of 2.0 mU/L.

Contact details for Joint Principal Investigator:
Professor Sir Nicholas Wald
Wolfson Institute of Preventive Medicine
Barts and The London, Queen Mary’s School of Medicine
Charterhouse Square
London
EC1M 6BQ
Email: n.j.wald@qmul.ac.uk

Scientific contact for the trial:
Dr Munir Abu-Helalah
Wolfson Institute of Preventive Medicine
Queen Mary University of London
Charterhouse Sqaure
London EC1M 6BQ
United Kingdom
Email: moneeraq@hotmail.com
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Thyroxine
Primary outcome measureTo determine how many participants feel better when taking thyroxine than placebo according to their own self-assessment, asked at the end of the 8 month trial.
Secondary outcome measuresTo assess the effects of thyroxine on:
1. General health
2. Symptom scores
3. Quality of life questionnaires
4. Cognitive function
5. Serum lipids

Measured at the start of the study and at the end of the four month thyroxine and placebo phases.
Overall study start date01/02/2006
Completion date31/05/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants60
Key inclusion criteria1. Women aged from 35 - 79 years, men aged from 65 - 79 years
2. Attended general screening at BUPA Wellness Centres between 1 January 2006 and 15 September 2007
3. Detected with thyroid stimulating hormone (TSH) greater than 4.0 mU/L
Key exclusion criteria1. People under current clinical surveillance for thyroid disease, or taking thyroxine, or having known pituitary or adrenal disease
2. People known to have coronary artery disease
3. People with any illness that in the doctor's opinion warranted exclusion from the trial
4. Diabetics taking insulin or oral hypoglycaemics, or people taking anticoagulants (warfarin or phenindinone)
5. People taking certain drugs that affect the serum concentration of TSH or free thyroxine
Date of first enrolment01/02/2006
Date of final enrolment31/05/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Wolfson Institute of Preventive Medicine
London
EC1M 6BQ
United Kingdom

Sponsor information

Queen Mary University of London (UK)
Research organisation

c/o Professor Malcolm Law
Wolfson Institute of Preventive Medicine
Charterhouse Square
London
EC1M 6BQ
United Kingdom

Website http://www.qmul.ac.uk/
ROR logo "ROR" https://ror.org/026zzn846

Funders

Funder type

Charity

BUPA Foundation (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Location
United Kingdom

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 01/06/2010 Yes No