drugset / Trial / NCT04354896

The Effect of Thyroid Hormone Therapy on Muscle Mass and Function in Older Adults With Subclinical Hypothyroidism

NCT04354896

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Subclinical hypothyroidism (SCH) is common among the elderly population and has been associated with neuromuscular impairment. Muscular symptoms such as weakness, myalgia and cramps are more often reported by SCH patients compared to euthyroid controls. Sarcopenia is the age-related loss of muscular mass and function and its assessment includes three dimensions (muscle quantity, muscle strength and physical performance). To date, evidence is lacking about the effect of thyroid hormone replacement on skeletal muscle impairment in SCH patients. The aim of the study is therefore to evaluate the impact of levothyroxine therapy on sarcopenia measures in SCH. This is a nested substudy within two large international multicenter randomized controlled trial of elderly participants with SCH (TRUST Study, clinicaltrials.gov ID NCT 01660126; and IEMO Study, Netherland Trial Register ID NTR3851). Those two trials shared a very similar study design. The cohorts will therefore be analyzed as a single study population.

Timeline

Start
2014-05
Primary completion
2018-05-04
Completion
2018-05-04

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Levothyroxine Other / unclassified 25 ug
Subject Levothyroxine Other / unclassified 50 ug
Subject Levothyroxine Other / unclassified 150 ug