Subclinical Hypothyroidism and Mind in the Elderly

Study Overview
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Brief Summary
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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
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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

Official Title
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Randomized Double Blind Levothyroxine vs Placebo, Mind (NEUROPSI) Improvement in Elderly With Persistent TSH 4-10 mUI/L

Conditions
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Subclinical Hypothyroidism

Intervention / Treatment
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* Drug: levothyroxine sodium
* Drug: excipient without levothyroxine (placebo)


Participation Criteria
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Eligibility Criteria
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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....)

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levothyroxine<br>Half of participants randomly assigned, take a pill daily, bimonthly thyroid test | Drug: levothyroxine sodium<br>* Daily intake (fasting) levothyroxine bimonthly adjusted; to keep TSH between 0.5 to 2.5 mUI/L range. Start with 12.5mcg an investigator other than the caregiver will review the TSH measurements to adjust levothyroxine dose that will contain the coded bottle with the pils given to patient.<br>* Other names: synthroid;|
| Placebo Comparator: Placebo<br>Half of participants randomly assigned, take a pill daily, bimonthly thyroid test | Drug: excipient without levothyroxine (placebo)<br>* Daily intake (fasting) a pill. bimonthly adjusted; an investigator other than the caregiver will review the TSH measurements and pretend to adjust dose contained in the coded bottle with the pills given to patient.<br>* Other names: sugar pills;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cognitive ability measured by NEUROPSI increase of 10 points |  | baseline and after 6 months of treatment | 
| ejection fraction, left ventricular diastolic capacity |  | baseline, after six months of treatment | 
| Lipid profile and body composition by DEXA |  | baseline, after six months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical assessment v.g. significant changes in cardiac frequency and rhythm (if needed able to take EKG to confirm) |  | bimonthly | 
| Free tiroxina and TSH (assessed by investigator other than treatment physician) |  | bimonthly | 
| Changes in EKG |  | baseline, at six months, or as needed | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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subclinical hypothyroidism, elderly, mild cognitive impairment, neuropsychological test, NEUROPSI