NL-OMON43858CompletedPhase 4
Multimodal effects of Thyroid hormone Replacement for Untreated older adults with Subclinical hypothyroidism* a randomised placebo controlled Trial - TRUST
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 188
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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).
Investigators
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