Effect of Thyroid Hormone Replacement on Fatigability in Untreated Older Adults With Subclinical Hypothyroidism

PHASE4CompletedINTERVENTIONAL
Enrollment

276

Participants

Timeline

Start Date

January 31, 2014

Primary Completion Date

April 5, 2018

Study Completion Date

April 5, 2018

Conditions
Thyroid DysfunctionMental FatigueFatigue
Interventions
DRUG

Levothyroxine

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 and \<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).

DRUG

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.~Pharmaceutical composition of placebo (100 mg): Lactose monohydrate 66 mg, Maize starch 25 mg, Gelatin 5 mg, Croscarmellose sodium 3.5 mg, Magnesium stearate (vegetable source) 0.5 mg."

Trial Locations (3)

1011

Department of General Internal Medicine, Lausanne

3010

Clinic for General Internal Medicine, Bern University Hospital Bern, Bern

Cork

University College Cork, National University of Ireland, Cork

All Listed Sponsors
collaborator

University College Cork

OTHER

collaborator

University of Lausanne Hospitals

OTHER

lead

Insel Gruppe AG, University Hospital Bern

OTHER

NCT02500342 - Effect of Thyroid Hormone Replacement on Fatigability in Untreated Older Adults With Subclinical Hypothyroidism | Biotech Hunter | Biotech Hunter