Clinical Trials Logo

Clinical Trial Summary

Subclinical hypothyroidism (SCH) is a common condition among older men and women. Although by definition SCH comprises biochemically mild thyroid hormone deficiency without overt symptoms, it is a possible contributor to multiple problems in older age. Thyroid hormone has 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 multisystem benefits to older people with SCH.

Small studies have reported reduced atherosclerosis and improved heart 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. 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). The investigators will include older men and women with a wide age range and of varying health status. Outcomes include health related quality of life, muscle strength, executive cognitive function and cardiovascular events, with a minimum of 1 year of follow up. Blood and urine samples will be stored in a biobank, to allow future research on causes of ill health in older people with 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. The proposal explores the multisystem 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 health care costs and promote healthy ageing of older adults.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT01660126
Study type Interventional
Source NHS Greater Glasgow and Clyde
Contact
Status Completed
Phase Phase 4
Start date May 2014
Completion date November 18, 2016

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05019118 - Dietary Intervention With Únicla Dairy Products (DANTIAN) N/A
Completed NCT01838031 - Thyroid Screening Protocol During Pregnancy: a Multi-center Prospective Controlled Study N/A
Completed NCT01335802 - Relation Between Subclinical Hypothyroidism and Outcome of Pregnancy
Terminated NCT00962221 - Lipids Profile in Subclinical Hypothyroidism N/A
Completed NCT00388297 - Thyroid Therapy for Mild Thyroid Deficiency in Pregnancy Phase 3
Completed NCT03898622 - Supplementation of Thyroid Hormone for TSH Control in Patients With Chronic Kidney Disease Without TRR. Phase 3
Completed NCT01985204 - Iodine Supplementation in Obesity N/A
Recruiting NCT06041204 - Best Treatment for Women With Both (Polycystic Ovary Syndrome) PCOS and Subclinical Hypothyroidism N/A
Completed NCT04354896 - The Effect of Thyroid Hormone Therapy on Muscle Mass and Function in Older Adults With Subclinical Hypothyroidism Phase 4
Completed NCT02090907 - Effects of Levothyroxine on Endothelial Function of Patients With Subclinical Hypothyroidism Phase 2/Phase 3
Completed NCT04288115 - Discontinuation of Levothyroxine Therapy for Patients With Subclinical Hypothyroidism Phase 4
Completed NCT01853579 - The TRUST Study - Depression Substudy Phase 4
Completed NCT00921050 - Subclinical Hypothyroidism and Mind in the Elderly Phase 2/Phase 3
Completed NCT00535561 - Iron Deficiency Anemia Can be an Indication for Treatment of Subclinical Hypothyroidism Phase 1
Completed NCT00498238 - The Effect of Levothyroxine on Arterial Stiffness and Lipid Profile in Patients With Subclinical Hypothyroidism N/A
Completed NCT03036956 - The Prevalence of Sub Clinical Hypothyroidism During Early Pregnancy in Pakistan N/A
Completed NCT02061111 - NeoThyr - the Role of Mitochondria-dysfunction in Newborns of Mothers With Autoimmune Thyroid Disease
Completed NCT01832753 - Treatment Trial of Subclinical Hypothyroidism in Down Syndrome N/A
Completed NCT02399475 - Mechanistic Study of Subclinical Hypothyroidism In the Elderly N/A
Completed NCT00437931 - Color Flow Doppler Ultrasound in Subclinical Thyroid Dysfunction N/A