Hypothyroidism. People with high thyroid stimulating hormone (TSH) serum level with normal or low free thyroxine.
Conditions
Interventions
Trade Name: Eltroxin 25 mcg
Product Name: Eltroxin 25 mcg
Pharmaceutical Form: Capsule*
INN or Proposed INN: Levothyroxine Sodium B.P
Concentration unit: µg microgram(s)
Concentration type: equal
Con
Sponsors
Queen Mary, University of London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Is it worthwhile to screen an adult population for hypothyroidism: do some people with previously undetected biochemical evidence of low thyroid function benefit symptomatically from thyroxine replacement therapy? ;Secondary Objective: ;Primary end point(s): 1. Each person will be asked which period of treatment they felt better on (thyroxine or placebo) without either the researcher of the participant knowing at the time which they were taking. 2. Thyroid specific clinical scores: the Zulewski score and the Billewicz score. 3. Memory and reaction times: Validated computerised tasks created by professor Andy Smith and colleagues (University of Cardiff). 4. Quality of life: Short Form Survey (SF-36) 5. Psychology: General Health Questionnaire-30 (GH-30) | — |
Countries
United Kingdom
Outcome results
None listed