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Study protocol: a randomised controlled trial on the clinical effects of levothyroxine treatment for subclinical hypothyroidism in people aged 80 years and over

Du Puy, R. S., Postmus, P. E., Stott, D. J., Blum, M. R., Poortvliet, R. K. E., Den Elzen, W. P. J., Peeters, R. P., van Munster, B. C., Wolffenbuttel, B. H. R., Westendorp, R. G. J., Kearney, P. M., Ford, I., Kean, S., Messow, C. M., Watt, T., Jukemal, J. W., Dekkers, O. M., Smit, J. W. A., Rodondi, N., Gussekloo, J. & Mooijaart, S. P., 19-Sep-2018, In : Bmc endocrine disorders. 18, 14 p., 67.

Research output: Contribution to journalArticleAcademicpeer-review

  • R. S. Du Puy
  • P.E. Postmus
  • D. J. Stott
  • M. R. Blum
  • R. K. E. Poortvliet
  • W. P. J. Den Elzen
  • R. P. Peeters
  • B. C. van Munster
  • B. H. R. Wolffenbuttel
  • R. G. J. Westendorp
  • P. M. Kearney
  • I. Ford
  • S. Kean
  • C. M. Messow
  • T. Watt
  • J. W. Jukemal
  • O. M. Dekkers
  • J. W. A. Smit
  • N. Rodondi
  • J. Gussekloo
  • S. P. Mooijaart

Background: Subclinical hypothyroidism is common in older people and its contribution to health and disease needs to be elucidated further. Observational and clinical trial data on the clinical effects of subclinical hypothyroidism in persons aged 80 years and over is inconclusive, with some studies suggesting harm and some suggesting benefits, translating into equipoise whether levothyroxine therapy provides clinical benefits. This manuscript describes the study protocol for the Institute for Evidence-Based Medicine in Old Age (IEMO) 80-plus thyroid trial to generate the necessary evidence base.

Methods: The IEMO 80-plus thyroid trial was explicitly designed as an ancillary experiment to the Thyroid hormone Replacement for Untreated older adults with Subclinical hypothyroidism randomised placebo controlled Trial (TRUST) with a near identical protocol and shared research infrastructure. Outcomes will be presented separately for the IEMO and TRUST 80-plus groups, as well as a pre-planned combined analysis of the 145 participants included in the IEMO trial and the 146 participants from the TRUST thyroid trial aged 80 years and over. The IEMO 80-plus thyroid trial is a multi-centre randomised double-blind placebo-controlled parallel group trial of levothyroxine treatment in community-dwelling participants aged 80 years and over with persistent subclinical hypothyroidism (TSH >= 4.6 and

Discussion: The combined analysis of participants in the IEMO 80-plus thyroid trial with the participants aged over 80 in the TRUST trial will provide the largest experimental evidence base on multimodal effects of levothyroxine treatment in 80-plus persons to date.

Original languageEnglish
Article number67
Number of pages14
JournalBmc endocrine disorders
Volume18
Publication statusPublished - 19-Sep-2018

    Keywords

  • Subclinical hypothyroidism, 80-plus, Randomised controlled trial, Quality of life, Levothyroxine, QUESTIONNAIRE, DISEASE, VERSION, VALIDITY, ADULTS, THYPRO

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