Thyroid hormone replacement for subclinical hypothyroidism

Phase 1

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

• Registration Number: EUCTR2011-004554-26-IE
• Lead Sponsor: niversity College Cork

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-12
• Last Update Posted: 6 February 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 3000

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 3000

Exclusion Criteria

• Subjects currently on Levothyroxine, antithyroid drugs, amiodarone or lithium.
• Recent thyroid surgery or radio-iodine (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).
• 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 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.

Study & Design

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