Effect of Thyroid Hormone Replacement on Fatigability in Untreated Older Adults With Subclinical Hypothyroidism
Status:
Completed
Trial end date:
2018-04-05
Target enrollment:
Participant gender:
Summary
Thyroid hormone is a key regulatory hormone for a range of physiological systems. An impaired
function of the thyroid gland such as subclinical hypothyroidism (SCH) can affect quality of
life. Older adults with subclinical hypothyroidism often report non-specific symptoms such as
tiredness. In addition, muscle symptoms such as cramps, weakness and myalgia are more common
in SCH than in healthy controls. At present, evidence is lacking about the benefits of
thyroxine replacement in the elderly with SCH, as no large randomized clinical trials (RCT)
on the full range of relevant clinical outcomes, including tiredness have been performed.
Moreover, there is continued uncertainty about the long-term impact on health related quality
of life of thyroxine treatment for SCH. The aim of the study is to examine, within a large
RCT of elderly participants with subclinical hypothyroidism, the impact of thyroxine therapy
on the association between subclinical thyroid disease (SCTD) and the level of physical and
mental fatigue. The existing trial infrastructure (TRUST thyroid trial-Euresearch FP7;
clinicaltrials.gov ID: NCT 01660126) will be utilized to collect information on the level of
physical and mental fatigue by using the Pittsburgh Fatigability Scale at baseline and at 1
year from 220 participants with persistent subclinical hypothyroidism randomized to either
thyroxine or placebo.
Phase:
Phase 4
Details
Lead Sponsor:
University Hospital Inselspital, Berne
Collaborators:
University College Cork University of Lausanne Hospitals