Cross-over randomised trial of adult hypothyroidism screening

Completed

• Conditions: Primary hypothyroidism; Nutritional, Metabolic, Endocrine; Other hypothyroidism

• Registration Number: ISRCTN00049084
• Lead Sponsor: Queen Mary University of London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-10
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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/

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
To assess the effects of thyroxine on:<br>1. General health<br>2. Symptom scores<br>3. Quality of life questionnaires<br>4. Cognitive function <br>5. Serum lipids<br><br>Measured at the start of the study and at the end of the four month thyroxine and placebo phases.