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Tools
Study protocol; Thyroid hormone Replacement for Untreated older adults with Subclinical hypothyroidism - a randomised placebo controlled Trial (TRUST)
,
Rudi G. J. Westendorp,
Simon Mooijaart,
Sharon Kean,
Terence J. Quinn,
Naveed Sattar,
Kirsty Hendry,
Robert Du Puy,
Wendy P. J. Den Elzen,
Wendy Den Elzen,
Rosalinde K. E. Poortvliet,
Jan W. A. Smit
and other authors.
Abstract
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