Skip to main content

Multi-modal effects of thyroid hormone replacement for untreated older adults with subclinical hypothyroidism; a randomised placebo-controlled trial

Objective

Subclinical hypothyroidism (SCH) is a common condition (8-18%) among European older men and women. Although by definition SCH comprises biochemically mild thyroid hormone deficiency without overt symptoms, it is a likely contributor to multiple problems in older age. Thyroid hormone has multiple pleiotropic effects on numerous physiological systems, including the vascular tree, heart, skeletal muscle and brain. Therefore, thyroxine substitution to overcome thyroid hormone deficiency has the potential to give multi-system benefits to older people with SCH. Small studies have reported reduced atherosclerosis and improved cardiac function with thyroxine replacement, but no large clinical trials have been performed. Therefore the available evidence is limited, leading to major variations in guidelines and clinical practice, with uncertainty regarding the indications for screening and treatment.
We are conducting a multicentre randomised placebo-controlled trial to assess the impact of thyroxine replacement. We have recruited 738 older adults with persisting SCH (excluding those in whom it is a temporary phenomenon who are less likely to benefit). We have included older men and women with a wide age range and of varying health status. Outcomes include health-related quality of life, cardiovascular events, muscle strength and executive cognitive function over 3-years of follow-up. We 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.
The proposal fits with the call, exploring the multi-system and quality-of-life benefits to older people of a tailored approach to management of SCH. This clinical trial should definitively clarify whether thyroxine treatment for SCH provides benefits that are relevant for patients. This trial will provide strong evidence with the potential to improve clinical practice, reduce healthcare costs and promote healthy ageing of European older adults.

Call for proposal

FP7-HEALTH-2011-two-stage
See other projects for this call

Coordinator

UNIVERSITY OF GLASGOW
Address
University Avenue
G12 8QQ Glasgow
United Kingdom
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 2 329 422,80
Administrative Contact
David J Stott (Prof.)

Participants (4)

UNIVERSITY COLLEGE CORK - NATIONAL UNIVERSITY OF IRELAND, CORK
Ireland
EU contribution
€ 1 111 161,60
Address
Western Road
T12 YN60 Cork
Activity type
Higher or Secondary Education Establishments
Administrative Contact
David O'connell (Dr.)
ACADEMISCH ZIEKENHUIS LEIDEN
Netherlands
EU contribution
€ 1 106 622
Address
Albinusdreef 2
2333 ZA Leiden
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Jacobijn Gussekloo (Prof.)
UNIVERSITAET BERN
Switzerland
EU contribution
€ 1 316 579,60
Address
Hochschulstrasse 6
3012 Bern
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Maddalena Tognola (Ms.)
LEYDEN ACADEMY ON VITALITY AND AGEING
Netherlands
EU contribution
€ 100 001
Address
Rijnsburgerweg Poortgb K 10
2333AA Leiden
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Rudi Westendorp (Prof.)