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

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dc.contributor.authorStott, David J.
dc.contributor.authorGussekloo, Jacobijn
dc.contributor.authorKearney, Patricia M.
dc.contributor.authorRodondi, Nicolas
dc.contributor.authorWestendorp, Rudi G. J.
dc.contributor.authorMooijaart, Simon P.
dc.contributor.authorKean, Sharon
dc.contributor.authorQuinn, Terence J.
dc.contributor.authorSattar, Naveed
dc.contributor.authorHendry, Kirsty
dc.contributor.authorDu Puy, Robert S.
dc.contributor.authorden Elzen, Wendy P. J.
dc.contributor.authorPoortvliet, Rosalinde K. E.
dc.contributor.authorSmit, Jan W. A.
dc.contributor.authorJukema, J. Wouter
dc.contributor.authorDekkers, Olaf M.
dc.contributor.authorBlum, Manuel R.
dc.contributor.authorCollet, Tinh-Hai
dc.contributor.authorMcCarthy, Vera J. C.
dc.contributor.authorHurley, Caroline
dc.contributor.authorByrne, Stephen
dc.contributor.authorBrowne, John P.
dc.contributor.authorWatt, Torquil
dc.contributor.authorBauer, Douglas C.
dc.contributor.authorFord, Ian
dc.contributor.funderSeventh Framework Programmeen
dc.date.accessioned2017-03-07T09:51:51Z
dc.date.available2017-03-07T09:51:51Z
dc.date.issued2017-02-03
dc.date.updated2017-03-06T18:30:21Z
dc.description.abstractBackground: 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.description.statusPeer revieweden
dc.description.versionPublished Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.citationStott, 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/s12902-017-0156-8en
dc.identifier.doi10.1186/s12902-017-0156-8
dc.identifier.endpage17en
dc.identifier.issn1472-6823
dc.identifier.issued6en
dc.identifier.journaltitleBMC Endocrine Disordersen
dc.identifier.startpage1en
dc.identifier.urihttps://hdl.handle.net/10468/3751
dc.identifier.volume17en
dc.language.isoenen
dc.publisherBioMed Centralen
dc.relation.projectinfo: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/TRUSTen
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.urihttps://creativecommons.org/licenses/by/4.0/en
dc.subjectSubclinical hypothyroidismen
dc.subjectElderlyen
dc.subjectRandomised controlled trialen
dc.subjectLevothyroxineen
dc.subjectQuality of lifeen
dc.subjectThyroid diseaseen
dc.titleStudy protocol; Thyroid hormone replacement for untreated older adults with subclinical hypothyroidism - a randomised placebo controlled trial (TRUST)en
dc.typeArticle (peer-reviewed)en
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