322
Participants
Start Date
May 31, 2014
Primary Completion Date
May 4, 2018
Study Completion Date
May 4, 2018
Levothyroxin
The intervention will start with Levothyroxine 50 mcg daily (reduced to 25 mcg in subjects \<50 kg of body weight or if known coronary heart disease - previous myocardial infarction or symptoms of angina pectoris) vs. matching placebo; at 3 months, if the serum TSH level is \<0.4 mU/L, dose will be reduced by 25 mcg; TSH 0.4 to 4.6 mU/L, no change to dose; TSH ≥4.6 mU/L, additional 25 mcg. The process will be repeated at 12 months, then annually; mock titration will be performed in the placebo group. The maximum possible dose of Levothyroxine which will be prescribed is 150 mcg (after 4 increments of 25 mcg at 3 months, 1, 2, 3 years; from the starting dose of 50 mcg).
Placebo
Control patients will obtain a placebo pill of the same characteristics as the intervention drug, and mock titration will be carried out identically to the intervention drug.
Department of General Internal Medicine, Lausanne
Clinic for General Internal Medicine, Bern University Hospital Bern, Bern
Department of Gerontology and Geriatrics, Leiden University Medical Center, Leiden
Department of Public Health and Primary Care, Leiden University Medical Center, Leiden
Institute for Evidence-Based Medicine in Old Age, Leiden
University of Lausanne Hospitals
OTHER
Leiden University Medical Center
OTHER
Insel Gruppe AG, University Hospital Bern
OTHER