Multi-modal effects of Thyroid hormone Replacement for Untreated older adults with Subclinical hypothyroidism; a randomised placebo-controlled Trial (TRUST) - Thyroid hormone replacement for subclinical hypothyroidism

Phase 1

• Conditions: Subclinical hypothyroidism; MedDRA version: 15.0 Level: LLT Classification code 10064627 Term: Subclinical hypothyroidism System Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2011-004554-26-GB
• Lead Sponsor: HS Greater Glasgow and Clyde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-07
• Study Completion: 2016-11-18
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 737

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: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
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 medication (eg. Carbimazole, methimazole, propylthiouracil, potassium percholate), 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. • 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 thyroxine treatment. In addition atrial fibrillation 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