Condition category
Nutritional, Metabolic, Endocrine
Date applied
29/01/2009
Date assigned
10/02/2009
Last edited
09/11/2011
Prospective/Retrospective
Retrospectively 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

Prof Malcolm Law

ORCID ID

Contact details

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

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 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 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

http://www.qmul.ac.uk/

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

  1. 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.

Additional files

Editorial Notes