IEMO 80-plus thyroid trial

Phase 1

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

• Registration Number: EUCTR2012-004160-22-NL
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-11
• Last Update Posted: 5 June 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

Community-dwelling patients aged >80 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 145

Exclusion Criteria

•Subjects currently on Levothyroxine or antithyroid medication (e.g. Carbimazole, methimazole, propylthiouracil, potassium percholate), 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 (within 4 weeks).
•Recent acute coronary syndrome, including myocardial infarction or unstable angina (within 4 weeks).
•Acute myocarditis ore acute pancarditis
•Untreated adrenal insufficiency
•Terminal illness.
•Patients known to have rare hereditary problem of galactose intolerance.
•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).

Study & Design

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