1 In addition, newborn screening of congenital hypothyroidism is crucial for the early detection and treatment of affected infants and contributes for the prevention of severe neurodevelopmental deficits associated with late diagnosis. When hypothyroidism is suspected, a prompt diagnosis and a proper treatment should be performed. Currently, hypothyroidism is usually diagnosed at early stages which allow a timely treatment. Plan to move out of the region in which the trial is being conducted within the next 2 years (proposed minimum follow-up period).However, some patients with normal thyroid hormone production have reduced action of the thyroid hormones at the tissue level and present with symptoms and signs of hypothyroidism.Subjects who are participating in ongoing RCTs of therapeutic interventions (including CTIMPs). ![]() Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.Recent acute coronary syndrome, including myocardial infarction or unstable angina (within 4 weeks).Recent hospitalisation for major illness or elective surgery (within 4 weeks).Recent thyroid surgery or radio-iodine (within 12 months).Subjects currently on Levothyroxine or antithyroid drugs, amiodarone or lithium.SCH is defined as elevated TSH levels (>=4.6, <=19.9 mU/L) and free thyroxine (fT4) in reference range measured on a minimum of two occasions at least 3 months apart. Community-dwelling patients aged >=65 years with Subclinical Hypothyroidism (SCH).This trial will provide strong evidence with the potential to improve clinical practice, reduce health care costs and promote healthy ageing of older adults. This clinical trial should definitively clarify whether thyroxine treatment for SCH provides benefits that are relevant for patients. The proposal explores the multisystem and quality of life benefits to older people of a tailored approach to management of SCH. The investigators have the support of patient advocacy groups and a consortium with the wide range of expertise and experience required to conduct large scale multicentre clinical trials. Blood and urine samples will be stored in a biobank, to allow future research on causes of ill health in older people with SCH. Outcomes include health related quality of life, muscle strength, executive cognitive function and cardiovascular events, with a minimum of 1 year of follow up. The investigators will include older men and women with a wide age range and of varying health status. The investigators propose a multicentre randomised placebo controlled trial to assess the impact of thyroxine replacement in a minimum of 540 older adults (maximum 750) with persisting SCH (excluding those in whom it is a temporary phenomenon who are unlikely to benefit). Therefore the available evidence is limited, leading to major variations in guidelines and clinical practice, with uncertainty regarding the indications for screening and treatment. Small studies have reported reduced atherosclerosis and improved heart function with thyroxine replacement, but no large clinical trials have been performed. Therefore, thyroxine substitution to overcome thyroid hormone deficiency has the potential to give multisystem benefits to older people with SCH. Thyroid hormone has effects on numerous physiological systems, including the vascular tree, heart, skeletal muscle and brain. ![]() ![]() Although by definition SCH comprises biochemically mild thyroid hormone deficiency without overt symptoms, it is a possible contributor to multiple problems in older age. Subclinical hypothyroidism (SCH) is a common condition among older men and women. ![]()
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