Study Results
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Basic Information
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COMPLETED
PHASE2/PHASE3
70 participants
INTERVENTIONAL
2009-06-30
2012-03-31
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Levothyroxine
Half of participants randomly assigned, take a pill daily, bimonthly thyroid test
levothyroxine sodium
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.
Placebo
Half of participants randomly assigned, take a pill daily, bimonthly thyroid test
excipient without levothyroxine (placebo)
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.
Interventions
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levothyroxine sodium
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.
excipient without levothyroxine (placebo)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Arrythmia
* Anticoagulant treatment
* Dementia
* Disease leading to dementia (acv, LIVER....)
60 Years
95 Years
ALL
No
Sponsors
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Universidad Autonoma de Nuevo Leon
OTHER
Responsible Party
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Lilia Csrdenas-Ibarra
MD
Principal Investigators
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Lilia Cardenas-Ibarra, M.D.
Role: PRINCIPAL_INVESTIGATOR
Endocrinology, University Hospital, Universidad Autonoma de Nuevo Leon
Jesus Z Villarreal-Perez, M.D.
Role: STUDY_CHAIR
Endocrinology, University Hospital, Universidad Autonoma de Nuevo Leon
Locations
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Endocrinology, Outpatient Hospital Clinic
Monterrey, Nuevo León, Mexico
Community Health Center (Fomerrey 19)
Monterrey, Nuevo León, Mexico
Countries
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Other Identifiers
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EN_LC_P136
Identifier Type: -
Identifier Source: org_study_id
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