IEMO 80-plus thyroid trial

Phase 4

Completed

Conditions: mildly underactive thyroid
10043739

Registration Number: NL-OMON44082

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 125

Inclusion Criteria

Community-dwelling patients aged over 80 years with SCH.;SCH is defined as persistently elevated TSH levels (TSH>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 or antithyroid medication (e.g. Carbimazole, methimazole, propylthiouracil, potassium percholate), 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 (within 4 weeks).
* Recent acute coronary syndrome, including myocardial infarction or unstable angina (within 4 weeks).
* Acute myocarditis ore acute pancarditis
* Untreated adrenal insufficiency or adrenal disorder
* Terminal illness.
* Patients known to have rare hereditary problem of galactose intolerance.
* 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 quality of life.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-General quality of life<br /><br>-Handgrip strength<br /><br>-Cognitive function, particularly executive function<br /><br>-Total mortality and cardiovascular mortality<br /><br>-Functional ability (basic Activities of Daily Living (ADL); extended<br /><br>activities of daily living)<br /><br>-Gait speed<br /><br>-Haemoglobin<br /><br>-Depressive symptoms<br /><br>-Fatal and non-fatal cardiovascular events (this will include acute myocardial<br /><br>infarction; stroke; amputations for peripheral vascular disease;<br /><br>revascularisations for atherosclerotic vascular disease, including for acute<br /><br>coronary syndrome and heart failure hospitalisations).</p><br>