Multimodal effects of Thyroid hormone Replacement for Untreated older adults with Subclinical hypothyroidism* a randomised placebo controlled Trial

Phase 4

Completed

Conditions: mildly underactive thyroid
10043739

Registration Number: NL-OMON43858

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 188

Inclusion Criteria

-Community-dwelling patients aged 65 years and over with subclinical hypothyroidism.
-Subclinical hypothyroidism 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

-Subjects currently on Levothyroxine, antithyroid drugs, amiodarone or lithium.
-Recent thyroid surgery or radio-iodine therapy (within 12 months).
-Grade IV NYHA heart failure.
-Prior clinical diagnosis of dementia.
-Recent hospitalisation for major illness or elective surgery (within 4 weeks).
-Recent acute coronary syndrome, including myocardial infarction or unstable angina (within 4 weeks).
-Acute myocarditis or acute pancarditis
-Untreated adrenal insufficiency and adrenal disorder
-Terminal illness.
-Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
-Subjects who are participating in ongoing RCTs of therapeutic interventions (including clinical trials of investigational medicinal products [CTIMPs])
-Plan to move out of the region in which the trial is being conducted within the next 2 years (proposed minimum follow-up period).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p> Change in disease specific QOL and symptom burden</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) General QOL<br /><br>2) Handgrip strength<br /><br>3) Cognitive function<br /><br>4) Total mortality<br /><br>5) Functional ability (basic and extended activities of daily living)<br /><br>6) Haemoglobin<br /><br>7) Depressive symptoms<br /><br>8) Fatal and non-fatal cardiovascular events</p><br>