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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

Page last updated: August 23, 2015

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