Phase 1

• Conditions: Subclinical hypothyroidism; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2011-004554-26-NL
• Lead Sponsor: eiden University Medical Center, division 3

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-04
• Last Update Posted: 22 May 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

Community-dwelling patients aged >=65 years with SCH.

SCH 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 750

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
•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).

Atrial fibrillation (sustained or paroxysmal) will not be an exclusion, as in itself this cardiac arrhythmia is not a contra-indication to Levothyroxine treatment. In addition, AF is a common finding in the studied age groups and exclusion of subjects with it would potentially compromise the generalisability of our results.

Adherence to treatment allocation: drop-ins (where subjects allocated to placebo are prescribed Levothyroxine) and drop outs (where subjects allocated to Levothyroxine stop this treatment) are each estimated at less than 5% at 1 year and less than 10% at the end of the study (mean 3 years follow-up).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified