Study protocol; Thyroid hormone Replacement for Untreated older adults with Subclinical hypothyroidism - a randomised placebo controlled Trial (TRUST).
- Stott DJ Geriatric Medicine, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK. David.J.Stott@glasgow.ac.uk.
- Gussekloo J Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, Netherlands.
- Kearney PM Department of Epidemiology and Public Health, University College Cork, Cork, Ireland.
- Rodondi N Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.
- Westendorp RG Leyden Academy on Vitality and Ageing, Leiden, Netherlands.
- Mooijaart S Department of Internal Medicine, Leiden University Medical Center, Leiden, Netherlands.
- Kean S Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.
- Quinn TJ Geriatric Medicine, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.
- Sattar N Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.
- Hendry K Geriatric Medicine, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.
- Du Puy R Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, Netherlands.
- Den Elzen WP Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Center, Leiden, The Netherlands.
- Poortvliet RK Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, Netherlands.
- Smit JW Radboud University Medical Center, Nijmegen, The Netherlands.
- Jukema JW Department of Cardiology, Leiden University Medical Center, Leiden, Netherlands.
- Dekkers OM Department of Internal Medicine, Leiden University Medical Center, Leiden, Netherlands.
- Blum M Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
- Collet TH Service of Endocrinology Diabetes and Metabolism, University Hospital of Laussanne, Lausanne, Switzerland.
- McCarthy V School of Nursing and Midwifery, University College Cork, Cork, Ireland.
- Hurley C Department of Epidemiology and Public Health and Clinical Research Facility, University College Cork, Cork, Ireland.
- Byrne S School of Pharmacy, University College Cork, Cork, Ireland.
- Browne J Department of Epidemiology and Public Health, University College Cork, Cork, Ireland.
- Watt T Department of Internal Medicine, Copenhagen University Hospital Herlev, Gentofte, Denmark.
- Bauer D Department of Medicine, University of California, San Francisco, USA.
- Ford I Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.
- 2017-02-05
Published in:
- BMC endocrine disorders. - 2017
Elderly
Levothyroxine
Quality of life
Randomised controlled trial
Subclinical hypothyroidism
Thyroid disease
Aged
Blood Banks
Clinical Protocols
Double-Blind Method
Hormone Replacement Therapy
Humans
Hypothyroidism
Patient Safety
Thyroxine
English
BACKGROUND
Subclinical hypothyroidism (SCH) is a common condition in elderly people, defined as elevated serum thyroid-stimulating hormone (TSH) with normal circulating free thyroxine (fT4). Evidence is lacking about the effect of thyroid hormone treatment. We describe the protocol of a large randomised controlled trial (RCT) of Levothyroxine treatment for SCH.
METHODS
Participants are community-dwelling subjects aged ≥65 years with SCH, diagnosed by elevated TSH levels (≥4.6 and ≤19.9 mU/L) on a minimum of two measures ≥ three months apart, with fT4 levels within laboratory reference range. The study is a randomised double-blind placebo-controlled parallel group trial, starting with levothyroxine 50 micrograms daily (25 micrograms in subjects <50Kg body weight or known coronary heart disease) with titration of dose in the active treatment group according to TSH level, and a mock titration in the placebo group. The primary outcomes are changes in two domains (hypothyroid symptoms and fatigue / vitality) on the thyroid-related quality of life questionnaire (ThyPRO) at one year. The study has 80% power (at p = 0.025, 2-tailed) to detect a change with levothyroxine treatment of 3.0% on the hypothyroid scale and 4.1% on the fatigue / vitality scale with a total target sample size of 750 patients. Secondary outcomes include general health-related quality of life (EuroQol), fatal and non-fatal cardiovascular events, handgrip strength, executive cognitive function (Letter Digit Coding Test), basic and instrumental activities of daily living, haemoglobin, blood pressure, weight, body mass index and waist circumference. Patients are monitored for specific adverse events of interest including incident atrial fibrillation, heart failure and bone fracture.
DISCUSSION
This large multicentre RCT of levothyroxine treatment of subclinical hypothyroidism is powered to detect clinically relevant change in symptoms / quality of life and is likely to be highly influential in guiding treatment of this common condition.
TRIAL REGISTRATION
Clinicaltrials.gov NCT01660126 ; registered 8th June 2012.
Subclinical hypothyroidism (SCH) is a common condition in elderly people, defined as elevated serum thyroid-stimulating hormone (TSH) with normal circulating free thyroxine (fT4). Evidence is lacking about the effect of thyroid hormone treatment. We describe the protocol of a large randomised controlled trial (RCT) of Levothyroxine treatment for SCH.
METHODS
Participants are community-dwelling subjects aged ≥65 years with SCH, diagnosed by elevated TSH levels (≥4.6 and ≤19.9 mU/L) on a minimum of two measures ≥ three months apart, with fT4 levels within laboratory reference range. The study is a randomised double-blind placebo-controlled parallel group trial, starting with levothyroxine 50 micrograms daily (25 micrograms in subjects <50Kg body weight or known coronary heart disease) with titration of dose in the active treatment group according to TSH level, and a mock titration in the placebo group. The primary outcomes are changes in two domains (hypothyroid symptoms and fatigue / vitality) on the thyroid-related quality of life questionnaire (ThyPRO) at one year. The study has 80% power (at p = 0.025, 2-tailed) to detect a change with levothyroxine treatment of 3.0% on the hypothyroid scale and 4.1% on the fatigue / vitality scale with a total target sample size of 750 patients. Secondary outcomes include general health-related quality of life (EuroQol), fatal and non-fatal cardiovascular events, handgrip strength, executive cognitive function (Letter Digit Coding Test), basic and instrumental activities of daily living, haemoglobin, blood pressure, weight, body mass index and waist circumference. Patients are monitored for specific adverse events of interest including incident atrial fibrillation, heart failure and bone fracture.
DISCUSSION
This large multicentre RCT of levothyroxine treatment of subclinical hypothyroidism is powered to detect clinically relevant change in symptoms / quality of life and is likely to be highly influential in guiding treatment of this common condition.
TRIAL REGISTRATION
Clinicaltrials.gov NCT01660126 ; registered 8th June 2012.
- Language
-
- English
- Open access status
- gold
- Identifiers
-
- DOI 10.1186/s12902-017-0156-8
- PMID 28158982
- Persistent URL
- https://folia.unifr.ch/global/documents/222560
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