Skip to content

Cross-over randomised trial of adult hypothyroidism screening

A double blind randomised cross-over trial to assess the value of screening an adult population for hypothyroidism

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN00049084
Enrollment
60
Registered
2009-02-10
Start date
2006-02-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary hypothyroidism Nutritional, Metabolic, Endocrine Other hypothyroidism

Interventions

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

Sponsors

Queen Mary University of London (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026