Study protocol; Thyroid hormone replacement for untreated older adults with subclinical hypothyroidism - a randomised placebo controlled trial (TRUST)

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dc.contributor.author Stott, David J.
dc.contributor.author Gussekloo, Jacobijn
dc.contributor.author Kearney, Patricia M.
dc.contributor.author Rodondi, Nicolas
dc.contributor.author Westendorp, Rudi G. J.
dc.contributor.author Mooijaart, Simon P.
dc.contributor.author Kean, Sharon
dc.contributor.author Quinn, Terence J.
dc.contributor.author Sattar, Naveed
dc.contributor.author Hendry, Kirsty
dc.contributor.author Du Puy, Robert S.
dc.contributor.author den Elzen, Wendy P. J.
dc.contributor.author Poortvliet, Rosalinde K. E.
dc.contributor.author Smit, Jan W. A.
dc.contributor.author Jukema, J. Wouter
dc.contributor.author Dekkers, Olaf M.
dc.contributor.author Blum, Manuel R.
dc.contributor.author Collet, Tinh-Hai
dc.contributor.author McCarthy, Vera J. C.
dc.contributor.author Hurley, Caroline
dc.contributor.author Byrne, Stephen
dc.contributor.author Browne, John P.
dc.contributor.author Watt, Torquil
dc.contributor.author Bauer, Douglas C.
dc.contributor.author Ford, Ian
dc.date.accessioned 2017-03-07T09:51:51Z
dc.date.available 2017-03-07T09:51:51Z
dc.date.issued 2017-02-03
dc.identifier.citation Stott, D.J., Gussekloo, J., Kearney, P.M., Rodondi, N., Westendorp, R.G., Mooijaart, S., Kean, S., Quinn, T.J., Sattar, N., Hendry, K. et al (2017) ‘Study protocol; Thyroid hormone replacement for untreated older adults with subclinical hypothyroidism-a randomised placebo controlled trial (TRUST)', BMC Endocrine Disorders, 17(6), pp.1-17. doi:10.1186/s12902-017-0156-8 en
dc.identifier.volume 17 en
dc.identifier.issued 6 en
dc.identifier.startpage 1 en
dc.identifier.endpage 17 en
dc.identifier.issn 1472-6823
dc.identifier.uri http://hdl.handle.net/10468/3751
dc.identifier.doi 10.1186/s12902-017-0156-8
dc.description.abstract Background: Subclinical hypothyroidism (SCH) is a common condition in elderly people, defined as elevated serum thyroid-stimulating hormone (TSH) with normal circulating free thyroxine (fT4). Evidence is lacking about the effect of thyroid hormone treatment. We describe the protocol of a large randomised controlled trial (RCT) of Levothyroxine treatment for SCH. Methods: Participants are community-dwelling subjects aged ≥65 years with SCH, diagnosed by elevated TSH levels (≥4.6 and ≤19.9 mU/L) on a minimum of two measures ≥ three months apart, with fT4 levels within laboratory reference range. The study is a randomised double-blind placebo-controlled parallel group trial, starting with levothyroxine 50 micrograms daily (25 micrograms in subjects <50Kg body weight or known coronary heart disease) with titration of dose in the active treatment group according to TSH level, and a mock titration in the placebo group. The primary outcomes are changes in two domains (hypothyroid symptoms and fatigue / vitality) on the thyroid-related quality of life questionnaire (ThyPRO) at one year. The study has 80% power (at p = 0.025, 2-tailed) to detect a change with levothyroxine treatment of 3.0% on the hypothyroid scale and 4.1% on the fatigue / vitality scale with a total target sample size of 750 patients. Secondary outcomes include general health-related quality of life (EuroQol), fatal and non-fatal cardiovascular events, handgrip strength, executive cognitive function (Letter Digit Coding Test), basic and instrumental activities of daily living, haemoglobin, blood pressure, weight, body mass index and waist circumference. Patients are monitored for specific adverse events of interest including incident atrial fibrillation, heart failure and bone fracture. Discussion: This large multicentre RCT of levothyroxine treatment of subclinical hypothyroidism is powered to detect clinically relevant change in symptoms / quality of life and is likely to be highly influential in guiding treatment of this common condition. en
dc.format.mimetype application/pdf en
dc.language.iso en en
dc.publisher BioMed Central en
dc.rights © 2017, the Authors. Open Access. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License, which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original authors and the source, provide a link to the Creative Commons license, and indicate if changes were made. en
dc.rights.uri https://creativecommons.org/licenses/by/4.0/ en
dc.subject Subclinical hypothyroidism en
dc.subject Elderly en
dc.subject Randomised controlled trial en
dc.subject Levothyroxine en
dc.subject Quality of life en
dc.subject Thyroid disease en
dc.title Study protocol; Thyroid hormone replacement for untreated older adults with subclinical hypothyroidism - a randomised placebo controlled trial (TRUST) en
dc.type Article (peer-reviewed) en
dc.internal.authorcontactother Patricia Kearney, Epidemiology & Public Health, University College Cork, Cork, Ireland. +353-21-490-3000 Email: patricia.kearney@ucc.ie en
dc.internal.availability Full text available en
dc.date.updated 2017-03-06T18:30:21Z
dc.description.version Published Version en
dc.internal.rssid 386090625
dc.contributor.funder Seventh Framework Programme en
dc.description.status Peer reviewed en
dc.identifier.journaltitle BMC Endocrine Disorders en
dc.internal.copyrightchecked Yes en
dc.internal.licenseacceptance Yes en
dc.internal.IRISemailaddress patricia.kearney@ucc.ie en
dc.relation.project info:eu-repo/grantAgreement/EC/FP7::SP1::HEALTH/278148/EU/Multi-modal effects of thyroid hormone replacement for untreated older adults with subclinical hypothyroidism; a randomised placebo-controlled trial/TRUST en


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© 2017, the Authors. Open Access. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License, which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original authors and the source, provide a link to the Creative Commons license, and indicate if changes were made. Except where otherwise noted, this item's license is described as © 2017, the Authors. Open Access. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License, which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original authors and the source, provide a link to the Creative Commons license, and indicate if changes were made.
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