Subclinical Hypothyroidism Clinical Trial
Official title:
Randomized Double Blind Levothyroxine vs Placebo, Mind (NEUROPSI) Improvement in Elderly With Persistent TSH 4-10 mUI/L
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.
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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