Thyroid Hormone Replacement for Subclinical Hypothyroidism

PHASE4CompletedINTERVENTIONAL
Enrollment

737

Participants

Timeline

Start Date

May 31, 2014

Primary Completion Date

November 18, 2016

Study Completion Date

November 18, 2016

Conditions
Subclinical Hypothyroidism
Interventions
DRUG

Levothyroxine

The intervention will start with Levothyroxine 50 µg daily (reduced to 25 µg in subjects \<50Kg body weight or if known coronary heart disease - previous myocardial infarction or symptoms of angina pectoris) versus matching placebo; at 3 months if the serum TSH level is \<0.4 mU/L dose will be reduced by 25 µg; TSH \>=0.4 and \<4.6 mU/L, no change to dose; TSH \>=4.6mUL, additional 25 µg. 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 that will be prescribed is 150μg.

DRUG

Placebo

Trial Locations (1)

G31 2ER

Glasgow Royal Infirmary, NHS Greater Glasgow and Clyde, Glasgow

All Listed Sponsors
collaborator

University of Glasgow

OTHER

collaborator

University College Cork

OTHER

collaborator

University of Bern

OTHER

collaborator

Leiden University Medical Center

OTHER

lead

NHS Greater Glasgow and Clyde

OTHER

NCT01660126 - Thyroid Hormone Replacement for Subclinical Hypothyroidism | Biotech Hunter | Biotech Hunter