Subclinical Hypothyroidism and Mind in the Elderly

Universidad Autonoma de Nuevo Leon

Status and phase: Completed; Phase 3; Phase 2

Conditions: Subclinical Hypothyroidism

Treatments: Drug: excipient without levothyroxine (placebo); Drug: levothyroxine sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT00921050

EN_LC_P136

Details and patient eligibility

About

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.

Full 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

Enrollment: 70 patients

Sex: All

Ages: 60 to 95 years old

Volunteers: No Healthy Volunteers

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....)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

70 participants in 2 patient groups, including a placebo group

Levothyroxine

Experimental group

Description:

Half of participants randomly assigned, take a pill daily, bimonthly thyroid test

Treatment:

Drug: levothyroxine sodium

Placebo

Placebo Comparator group

Description:

Half of participants randomly assigned, take a pill daily, bimonthly thyroid test

Treatment:

Drug: excipient without levothyroxine (placebo)