NCT00921050

Subclinical Hypothyroidism and Mind in the Elderly

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Universidad Autonoma de Nuevo Leon · Academic / Other
• Sex: All
• Age: 60 Years – 95 Years
• Healthy volunteers: Not accepted

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

Conditions

• Subclinical Hypothyroidism

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2009-06-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2009-06-16
• Last updated: 2012-06-28

Locations

2 sites across 1 country: Mexico