Effect of Thyroid Hormone Replacement on Fatigability in Untreated Older Adults With Subclinical Hypothyroidism
Information source: University Hospital Inselspital, Berne
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Thyroid Dysfunction; Mental Fatigue; Fatigue
Intervention: Levothyroxine (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University Hospital Inselspital, Berne Official(s) and/or principal investigator(s): Nicolas Rodondi, MD MAS, Principal Investigator, Affiliation: Clinic for General Internal Medicine, Bern University Hospital Bern
Overall contact: Nicolas Rodondi, MD MAS, Phone: + 41 31 632 41 63, Email: nicolas.rodondi@insel.ch
Summary
Thyroid hormone is a key regulatory hormone for a range of physiological systems. An
impaired function of the thyroid gland such as subclinical hypothyroidism (SCH) can affect
quality of life. Older adults with subclinical hypothyroidism often report non-specific
symptoms such as tiredness. In addition, muscle symptoms such as cramps, weakness and
myalgia are more common in SCH than in healthy controls. At present, evidence is lacking
about the benefits of thyroxine replacement in the elderly with SCH, as no large randomized
clinical trials (RCT) on the full range of relevant clinical outcomes, including tiredness
have been performed. Moreover, there is continued uncertainty about the long-term impact on
health related quality of life of thyroxine treatment for SCH. The aim of the study is to
examine, within a large RCT of elderly participants with subclinical hypothyroidism, the
impact of thyroxine therapy on the association between subclinical thyroid disease (SCTD)
and the level of physical and mental fatigue. The existing trial infrastructure (TRUST
thyroid trial-Euresearch FP7; clinicaltrials. gov ID: NCT 01660126) will be utilized to
collect information on the level of physical and mental fatigue by using the Pittsburgh
Fatigability Scale at baseline and at 1 year from 220 participants with persistent
subclinical hypothyroidism randomized to either thyroxine or placebo.
Clinical Details
Official title: Effect of Thyroid Hormone Replacement on Fatigability in Untreated Older Adults With Subclinical Hypothyroidism
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change from baseline in level of mental fatigue as assessed by the Pittsburgh Fatigability Scale (PFS) score
Secondary outcome: Level of mental fatigue as assessed by the PFS score
Detailed description:
Background
Thyroid hormone is a key regulatory hormone for a range of physiological systems. An
impaired function of the thyroid gland such as subclinical hypothyroidism (SCH) can affect
quality of life. Older adults with subclinical hypothyroidism often report non-specific
symptoms such as tiredness. In addition, muscle symptoms such as cramps, weakness and
myalgia are more common in SCH than in healthy controls. At present, evidence is lacking
about the benefits of thyroxine replacement in the elderly with SCH, as no large randomized
clinical trials (RCT) on the full range of relevant clinical outcomes, including tiredness
have been performed. Moreover, there is continued uncertainty about the long-term impact on
health related quality of life of thyroxine treatment for SCH.
Objective
To examine, within a large RCT of elderly participants with subclinical hypothyroidism (the
TRUST trial), the impact of thyroxine therapy on the association between subclinical thyroid
disease (SCTD) and the level of physical and mental fatigue.
Methods
The existing trial infrastructure (TRUST thyroid trial-Euresearch FP7, clinicaltrials. gov
ID: NCT 01660126) will be utilized to collect information on the level of physical and
mental fatigue by using the Pittsburgh Fatigability Scale at baseline and at 1 year from 220
participants with persistent subclinical hypothyroidism randomized to either thyroxine or
placebo.
Eligibility
Minimum age: 65 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Community-dwelling patients aged >= 65 years with subclinical hypothyroidism
- Written informed consent
Exclusion Criteria
- Subjects currently under Levothyroxine or antithyroid drugs (amiodarone, lithium)
- Recent thyroid surgery or radio-iodine (within 12 months)
- Grade IV NYHA heart failure
- Prior clinical diagnosis of dementia
- Recent hospitalization for major illness or elective surgery (within 4 weeks)
- Terminal illness
- Patients with rare hereditary problems of galactose intolerance, the Lapp lactase
deficiency or glucose-galactose malabsorption
- Subjects who are participating in ongoing RCTs of therapeutic interventions
(including CTIMPs)
- Plan to move out of the region in which the trial is being conducted within the next
2 years (proposed minimum follow-up period)
Locations and Contacts
Nicolas Rodondi, MD MAS, Phone: + 41 31 632 41 63, Email: nicolas.rodondi@insel.ch
University College Cork, National University of Ireland, Cork Cork, Ireland; Recruiting Patricia M Kearney, MD, MB, BAO, BCh, PhD, Sub-Investigator
Clinic for General Internal Medicine, Bern University Hospital Bern, Bern 3010, Switzerland; Recruiting Nicolas Rodondi, MD MAS, Principal Investigator
Department of General Internal Medicine, Lausanne, Vaud 1011, Switzerland; Recruiting Nelly Pitteloud, MD, Sub-Investigator
Additional Information
Related publications: Razvi S, Ingoe L, Keeka G, Oates C, McMillan C, Weaver JU. The beneficial effect of L-thyroxine on cardiovascular risk factors, endothelial function, and quality of life in subclinical hypothyroidism: randomized, crossover trial. J Clin Endocrinol Metab. 2007 May;92(5):1715-23. Epub 2007 Feb 13.
Starting date: January 2014
Last updated: July 13, 2015
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