Subclinical hypothyroidism Levothyroxin Older adults Randomized placebo-controlled trial Subklinische hypothyreoidie Levothyroxine Ouderen Gerandomiseerd placebo-gecontrolleerde trial
Conditions
Interventions
Oral Levothyroxine 50 µg daily (reduced to 25 mcg daily in subjects < 50 kg body weight or if known coronary heart disease) versus matching placebo. The intervention will have a maximum of 3 years.
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Inclusion criteria
Inclusion criteria: Community-dwelling patients aged >80 years with SCH. SCH is defined as persistently elevated TSH levels (>4.6 and ≤19.9 mU/L) and free thyroxine (fT4) in reference range measured on a minimum of two occasions at least 3 months apart.
Exclusion criteria
Exclusion criteria: 1. Subjects currently on Levothyroxine or antithyroid medication (e.g. Carbimazole, methimazole, propylthiouracil, potassium percholate), amiodarone or lithium; 2. Recent thyroid surgery or radio-iodine therapy (within 12 months); 3. Grade IV NYHA heart failure; 4. Prior clinical diagnosis of dementia; 5. Recent hospitalisation for major illness (within 4 weeks); 6. Recent acute coronary syndrome, including myocardial infarction or unstable angina (within 4 weeks); 7. Acute myocarditis ore acute pancarditis; 8. Untreated adrenal insufficiency; 9. Terminal illness; 10. Patients known to have rare hereditary problem of galactose intolerance; 11. Subjects who are participating in ongoing RCTs of therapeutic interventions (including clinical trials of investigational medicinal products [CTIMPs]); 12. Plan to move out of the region in which the trial is being conducted within the next 2 years (proposed minimum follow-up period).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoint is change in thyroid-specific quality of life and symptom burden assessed using the hypothyroid symptoms scale score and tiredness symptoms scale score on the thyroid-specific quality of life (ThyPRO) questionnaire at baseline, six to eight weeks and 12 months after recruitment and at the close-out visit are included. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. General quality of life; 2. Handgrip strength; 3. Cognitive function, particularly executive function; 4. Total mortality and cardiovascular mortality; 5. Functional ability (basic Activities of Daily Living (ADL); extended activities of daily living); 6. Gait speed; 7. Depressive symptoms. 8. Fatal and non-fatal cardiovascular events (this will include acute myocardial infarction; stroke; amputations for peripheral vascular disease; revascularisations for atherosclerotic vascular disease, including for acute coronary syndrome and heart failure hospitalisations) | — |
Contacts
Public ContactSimon Mooijaart
P.O.Box 9600
Outcome results
None listed