Clinical trial NCT00921050: Subclinical Hypothyroidism and Mind in the Elderly
Official title: Randomized Double Blind Levothyroxine vs Placebo, Mind (NEUROPSI) Improvement in Elderly With Persistent TSH 4-10 mUI/L
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Subclinical Hypothyroidism
Keywords: subclinical hypothyroidism
elderly
mild cognitive impairment
neuropsychological test
NEUROPSI
Lead sponsor: Universidad Autonoma de Nuevo Leon
Sponsor class: OTHER
First posted: 2009-06-16
Enrollment: 70
Sex: ALL
Minimum age (years): 60
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Some recommendations of expert consensus on subclinical hypothyroidism (SH) are controversial in those areas with not enough information to reach a conclusion, such as not recommending treatment with thyrotrophic hormone of 4-10 mUI/L and free thyroxin in normal range. The body changes or symptoms at this stage are often mistaken as aging. There are studies showing significant changes in heart (slow rate, lower ejection fraction, diastolic dysfunction); hypercholesterolemia, dysfunction cognitive abilities (memory attention...).

The prevalence of SH increases with age, reaching 14% over 65 years old. This age group increase as the population ages highlights the need for evidence to improve recommendations for the elderly.

NEUROPSI is a validated neuropsychological test sensible for mild cognitive alterations. It can be applied to individuals with little schooling.

This study aims to determine positive change in cognitive abilities (NEUROPSI), ejection fraction, and body percent of lean and adipose tissue without adverse effects, placebo versus thyroxin supplement to keep thyroid-stimulating hormone (TSH) between 0.5-2.5 mUI/L in elderly with TSH 4-10 mIU/L.

Detailed description: Screening, subjects \> 59 y/o with out exclusion criteria to identify HS, started in October 15, 2008. Due to difficulties getting the placebo for the assay, by January halted the screening. At the end of May we got the donation from Merck pharmaceuticals.

The protocol original dates changed as follows:

* Restart screening June 20 to end in August 2009;
* Enrolling start at the end of June (the already identified);
* End enrolling October 2009;
* Follow up will end in May 2010.

Note: 150 of the screened subjects will be from randomly selected homes at Fomerrey 19 to allow prevalence estimation.

* Enroling ended until june 2010
* Follow up stil ungoing final measures will be done at the end of 2011

Eligibility criteria: Inclusion Criteria:

* TSH between 4 and 10 mUI/L inclusive

Exclusion Criteria:

* Known and treatment of thyroideal disease
* Arrythmia
* Anticoagulant treatment
* Dementia
* Disease leading to dementia (acv, LIVER....)

Primary outcomes:
measure: Change in cognitive ability measured by NEUROPSI increase of 10 points
timeFrame: baseline and after 6 months of treatment
measure: ejection fraction, left ventricular diastolic capacity
timeFrame: baseline, after six months of treatment
measure: Lipid profile and body composition by DEXA
timeFrame: baseline, after six months of treatment
Secondary outcomes:
measure: clinical assessment v.g. significant changes in cardiac frequency and rhythm (if needed able to take EKG to confirm)
timeFrame: bimonthly
measure: Free tiroxina and TSH (assessed by investigator other than treatment physician)
timeFrame: bimonthly
measure: Changes in EKG
timeFrame: baseline, at six months, or as needed
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Endocrinology, Outpatient Hospital Clinic
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Community Health Center (Fomerrey 19)
state: Nuevo Leon
Study officials:
affiliation: Endocrinology, University Hospital, Universidad Autonoma de Nuevo Leon
name: Lilia Cardenas-Ibarra, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Endocrinology, University Hospital, Universidad Autonoma de Nuevo Leon
name: Jesus Z Villarreal-Perez, M.D.
role: STUDY_CHAIR
References: