Subclinical Hypothyroidism and Mind in the Elderly

Subclinical Hypothyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00921050
• Other study ID #: EN_LC_P136
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 15, 2009
• Last updated: June 27, 2012
• Start date: June 2009
• Est. completion date: March 2012

Study information

• Verified date: June 2010
• Source: Universidad Autonoma de Nuevo Leon
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 95 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypothyroidism
• Subclinical Hypothyroidism

Intervention

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.
• 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.

Locations

Country	Name	City	State
Mexico	Community Health Center (Fomerrey 19)	Monterrey	Nuevo Leon
Mexico	Endocrinology, Outpatient Hospital Clinic	Monterrey	Nuevo Leon

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de Nuevo Leon

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cognitive ability measured by NEUROPSI increase of 10 points		baseline and after 6 months of treatment	No
Primary	ejection fraction, left ventricular diastolic capacity		baseline, after six months of treatment	No
Primary	Lipid profile and body composition by DEXA		baseline, after six months of treatment	No
Secondary	clinical assessment v.g. significant changes in cardiac frequency and rhythm (if needed able to take EKG to confirm)		bimonthly	Yes
Secondary	Free tiroxina and TSH (assessed by investigator other than treatment physician)		bimonthly	Yes
Secondary	Changes in EKG		baseline, at six months, or as needed	Yes