Double blind randomised cross-over trial to assess the value of screening an adult population for hypothyroidism - CROSS OVER RANDOMISED TRIAL OF ADULT HYPOTHROIDISM SCREENING
- Conditions
- Hypothyroidism. People with high thyroid stimulating hormone (TSH) serum level with normal or low free thyroxine.
- Registration Number
- EUCTR2005-003464-30-GB
- Lead Sponsor
- Queen Mary, University of London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Participants will already be attending a BUPA Wellness screening centre where they will expect to have a general health assessment and screening for a range of disorders. TSH is routinely measured in women aged 50-79 and men aged 65-79. These age groups therefore constitute the inclusion criteria for the trial: they are appropriate because hypothyroidism is more common in women. We will be using sex-specific normal” ranges.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. People under current clinical surveillance for thyroid disease, or taking thyroxine.
2. Pituitary or adrenal disease.
3. Coronary heart disease: angina pectoris, arteriosclerosis, coronary artery disease, previous myocardial infarction (because the thyroxine dose must be increased more gradually in these patients to be certain of avoiding thyrotoxicosis, which may precipitate myocardial infarction).
4. Cancer or other serious illness.
5. Taking drugs that affect TSH secretion or thyroid hormone secretion, absorption, transport or metabolism.
6.Taking drugs used to treat diabetes, and antigoagulants.
7. Hypersensitivity to levothyroxine, microcrystalline cellulose, gelatine or any other ingredients of the tablets (lactose, magnesium stearate, maize starch, pregelatinised maize starch, Stearic acid, Sodium citrate and powdered acacia)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method