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Clinical Trials/NL-OMON43858
NL-OMON43858CompletedPhase 4

Multimodal effects of Thyroid hormone Replacement for Untreated older adults with Subclinical hypothyroidism* a randomised placebo controlled Trial - TRUST

eids Universitair Medisch Centrum0 sites188 target enrollmentStarted: TBDLast updated:
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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