IEMO 80-plus thyroid trial.

Recruiting

Conditions: Subclinical hypothyroidismLevothyroxinOlder adults Randomized placebo-controlled trialSubklinische hypothyreoidieLevothyroxineOuderenGerandomiseerd placebo-gecontrolleerde trial

Registration Number: NL-OMON22581

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Trial Results Mooijaart SP, Du Puy RS, Stott DJ, Kearney PM, Rodondi N, Westendorp RGJ, den Elzen WPJ, Postmus I, Poortvliet RKE, van Heemst D, van Munster BC, Peeters RP, Ford I, Kean S, Messow CM, Blum MR, Collet TH, Watt T, Dekkers OM, Jukema JW, Smit JWA, Langhorne P, Gussekloo J. Association Between Levothyroxine Treatment and Thyroid-Related Symptoms Among Adults Aged 80 Years and Older With Subclinical Hypothyroidism. JAMA. 2019 Oct 30:1-11. doi: 10.1001/jama.2019.17274. [Epub ahead of print] PubMed PMID: 31664429; PubMed Central PMCID: PMC6822162. Methods paper Du Puy RS, Postmus I, Stott DJ, Blum MR, Poortvliet RKE, Den Elzen WPJ, Peeters RP, van Munster BC, Wolffenbuttel BHR, Westendorp RGJ, Kearney PM, Ford I, Kean S, Messow CM, Watt T, Jukema JW, Dekkers OM, Smit JWA, Rodondi N, Gussekloo J, Mooijaart SP. Study protocol: a randomised controlled trial on the clinical effects of levothyroxine treatment for subclinical hypothyroidism in people aged 80 years and over. BMC Endocr Disord. 2018 Sep 19;18(1):67. doi: 10.1186/s12902-018-0285-8. PubMed PMID: 30231866; PubMed Central PMCID: PMC6146605.

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 145

Inclusion Criteria

Community-dwelling patients aged >80 years with SCH.

Exclusion Criteria

1. Subjects currently on Levothyroxine or antithyroid medication (e.g. Carbimazole, methimazole, propylthiouracil, potassium percholate), amiodarone or lithium;

2. Recent thyroid surgery or radio-iodine therapy (within 12 months);

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main study endpoint is change in thyroid-specific quality of life and symptom burden assessed using the hypothyroid symptoms scale score and tiredness symptoms scale score on the thyroid-specific quality of life (ThyPRO) questionnaire at baseline, six to eight weeks and 12 months after recruitment and at the close-out visit are included.

Secondary Outcome Measures

Name	Time	Method
1. General quality of life;<br>2. Handgrip strength;<br>3. Cognitive function, particularly executive function;<br>4. Total mortality and cardiovascular mortality;<br>5. Functional ability (basic Activities of Daily Living (ADL); extended activities of daily living);<br>6. Gait speed;<br>7. Depressive symptoms.<br>8. Fatal and non-fatal cardiovascular events (this will include acute myocardial infarction; stroke; amputations for peripheral vascular disease; revascularisations for atherosclerotic vascular disease, including for acute coronary syndrome and heart failure hospitalisations)