Subclinical Hypothyroidism and Mind in the Elderly

Phase 2

Completed

• Conditions: Subclinical Hypothyroidism
• Interventions: Drug: excipient without levothyroxine (placebo); Drug: levothyroxine sodium

• Registration Number: NCT00921050
• Lead Sponsor: Universidad Autonoma de Nuevo Leon

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

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-15
• Study First Submitted QC: 2009-06-15
• Study First Posted: 2009-06-16
• Status Verified: 2010-06
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Last Update Submitted: 2012-06-27
• Last Update Posted: 2012-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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....)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	excipient without levothyroxine (placebo)	Half of participants randomly assigned, take a pill daily, bimonthly thyroid test
Levothyroxine	levothyroxine sodium	Half of participants randomly assigned, take a pill daily, bimonthly thyroid test

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

Community Health Center (Fomerrey 19); 🇲🇽 Monterrey, Nuevo Leon, Mexico

Endocrinology, Outpatient Hospital Clinic; 🇲🇽 Monterrey, Nuevo Leon, Mexico