Study protocol; Thyroid hormone Replacement for Untreated older adults with Subclinical hypothyroidism - a randomised placebo controlled Trial (TRUST)
| العنوان: | Study protocol; Thyroid hormone Replacement for Untreated older adults with Subclinical hypothyroidism - a randomised placebo controlled Trial (TRUST) |
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| المؤلفون: | Rudi G. J. Westendorp, Vera J. C. McCarthy, Simon P. Mooijaart, Rosalinde K. E. Poortvliet, Patricia M. Kearney, Jacobijn Gussekloo, David J. Stott, Kirsty Hendry, Stephen Byrne, Wendy P. J. den Elzen, Terence J. Quinn, Douglas C. Bauer, Manuel R. Blum, Torquil Watt, Olaf M. Dekkers, Robert S. Du Puy, Nicolas Rodondi, Ian Ford, Tinh-Hai Collet, Naveed Sattar, Jan W. A. Smit, Caroline Hurley, J. Wouter Jukema, Sharon Kean, John Browne |
| المصدر: | Stott, David J; Gussekloo, Jacobijn; Kearney, Patricia M; Rodondi, Nicolas; Westendorp, Rudi G J; Mooijaart, Simon; Kean, Sharon; Quinn, Terence J; Sattar, Naveed; Hendry, Kirsty; Du Puy, Robert; Den Elzen, Wendy P J; Poortvliet, Rosalinde K E; Smit, Jan W A; Jukema, J Wouter; Dekkers, Olaf M; Blum, Manuel; Collet, Tinh-Hai; McCarthy, Vera; Hurley, Caroline; ... (2017). Study protocol; Thyroid hormone Replacement for Untreated older adults with Subclinical hypothyroidism-a randomised placebo controlled Trial (TRUST). BMC Endocrine Disorders, 17(1), p. 6. BioMed Central 10.1186/s12902-017-0156-8 <http://dx.doi.org/10.1186/s12902-017-0156-8Test> Stott, DJ; Gussekloo, J; Kearney, PM; Rodondi, N; Westendorp, RGJ; Mooijaart, S; 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(1). doi: 10.1186/s12902-017-0156-8. UCSF: Retrieved from: http://www.escholarship.org/uc/item/5s9116b6Test BMC Endocrine Disorders Stott, D J, Gussekloo, J, Kearney, P M, Rodondi, N, Westendorp, R G J, Mooijaart, S P, Kean, S, Quinn, T J, Sattar, N, Hendry, K, Du Puy, R, Den Elzen, W P J, Poortvliet, R K E, Smit, J W A, Jukema, J W, Dekkers, O M, Blum, M, Collet, T-H, McCarthy, V, Hurley, C, Byrne, S, Browne, J, Watt, T, Bauer, D & Ford, I 2017, ' Study protocol; Thyroid hormone Replacement for Untreated older adults with Subclinical hypothyroidism : a randomised placebo controlled Trial (TRUST) ', B M C Endocrine Disorders, vol. 17, 6, pp. 1-17 . https://doi.org/10.1186/s12902-017-0156-8Test BMC Endocrine Disorders, 17 BMC endocrine disorders, vol 17, iss 1 BMC Endocrine Disorders, 17, 1-17 BMC endocrine disorders, vol. 17, no. 1, pp. 6 |
| بيانات النشر: | BioMed Central, 2017. |
| سنة النشر: | 2017 |
| مصطلحات موضوعية: | Aging, Endocrinology, Diabetes and Metabolism, Placebo-controlled study, Levothyroxine, Cardiovascular, law.invention, Study Protocol, 0302 clinical medicine, Elderly, Thyroid Hormone Treatment, Randomized controlled trial, Clinical Protocols, law, Subclinical hypothyroidism, 030212 general & internal medicine, Subclinical infection, 2. Zero hunger, Randomised controlled trial, Thyroid disease, General Medicine, 3. Good health, Heart Disease, 6.1 Pharmaceuticals, Randomized Controlled Trial, Blood Banks, Patient Safety, medicine.drug, Quality of life, medicine.medical_specialty, Hormone Replacement Therapy, Clinical Trials and Supportive Activities, Clinical Sciences, 030209 endocrinology & metabolism, 610 Medicine & health, Metabolic and Endocrine, Healthcare improvement science Radboud Institute for Health Sciences [Radboudumc 18], 03 medical and health sciences, Endocrinology & Metabolism, Double-Blind Method, Hypothyroidism, Clinical Research, 360 Social problems & social services, Internal medicine, Behavioral and Social Science, medicine, Journal Article, Humans, Aged, business.industry, Evaluation of treatments and therapeutic interventions, medicine.disease, R1, Thyroxine, Good Health and Well Being, Heart failure, Physical therapy, business, Body mass index, Hypothyroidism/drug therapy, Thyroxine/administration & dosage |
| الوصف: | 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 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.Trial registration: Clinicaltrials.gov NCT01660126; registered 8th June 2012. |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 1472-6823 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::35d6414678ff7d54612d97162a95b433Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....35d6414678ff7d54612d97162a95b433 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 14726823 |
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