Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CTHS02
Study information
Scientific title
A double blind randomised cross-over trial to assess the value of screening an adult population for hypothyroidism
Acronym
HSS
Study hypothesis
People detected with high thyroid stimulating hormone (TSH) through general screening respond symptomatically to thyroxine.
Ethics approval
Oxfordshire Research Ethics Committee A gave approval on the 7th June 2005 (ref: 05/Q1604/67)
Study design
Single centre double-blind randomised cross-over trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Can be found at: http://www.wolfson.qmul.ac.uk/hssleaflet/hssleaflet.pdf
Condition
Primary hypothyroidism
Intervention
Each 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 Marys 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 type
Drug
Phase
Not Applicable
Drug names
Thyroxine
Primary outcome measures
To 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 measures
To 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 trial start date
01/02/2006
Overall trial end date
31/05/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. 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
Recruitment start date
01/02/2006
Recruitment end date
31/05/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Wolfson Institute of Preventive Medicine
London
EC1M 6BQ
United Kingdom
Sponsor information
Organisation
Queen Mary University of London (UK)
Sponsor details
c/o Professor Malcolm Law
Wolfson Institute of Preventive Medicine
Charterhouse Square
London
EC1M 6BQ
United Kingdom
Sponsor type
Research organisation
Website
Funders
Funder type
Charity
Funder name
BUPA Foundation (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
United Kingdom
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
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21258125
Publication citations
-
Results
Abu-Helalah M, Law MR, Bestwick JP, Monson JP, Wald NJ, A randomized double-blind crossover trial to investigate the efficacy of screening for adult hypothyroidism., J Med Screen, 2010, 17, 4, 164-169, doi: 10.1258/jms.2010.010057.