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
Scientific
Wolfson Institute of Preventive Medicine
Queen Mary University of London
Charterhouse Square
London
EC1M 6BQ
United Kingdom
Study information
| Study design | Single centre double-blind randomised cross-over trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Can be found at: http://www.wolfson.qmul.ac.uk/hssleaflet/hssleaflet.pdf |
| Scientific title | A double blind randomised cross-over trial to assess the value of screening an adult population for hypothyroidism |
| Study acronym | HSS |
| Study objectives | People 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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Thyroxine |
| Primary outcome measure | 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 study start date | 01/02/2006 |
| Completion date | 31/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2006 |
| Date of final enrolment | 31/05/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Wolfson Institute of Preventive Medicine
London
EC1M 6BQ
United Kingdom
EC1M 6BQ
United Kingdom
Sponsor information
Queen Mary University of London (UK)
Research organisation
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" |
https://ror.org/026zzn846 |
Funders
Funder type
Charity
BUPA Foundation (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
