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Completed

NCT Number: NCT00921050

Subclinical Hypothyroidism and Mind in the Elderly

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.

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Key information

Conditions

Subclinical Hypothyroidism Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

60 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Community Health Center (Fomerrey 19), Monterrey, Nuevo León, Mexico

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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....)

Treatment and study plan

Levothyroxine Sodium

Drug

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.

Other names: eutirox (Merck), synthroid

excipient without levothyroxine (placebo)

Drug

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 names: sugar pills

Primary outcomes

  1. Change in cognitive ability measured by NEUROPSI increase of 10 points

    Time frame: baseline and after 6 months of treatment

  2. ejection fraction, left ventricular diastolic capacity

    Time frame: baseline, after six months of treatment

  3. Lipid profile and body composition by DEXA

    Time frame: baseline, after six months of treatment

Secondary outcomes

  1. clinical assessment v.g. significant changes in cardiac frequency and rhythm (if needed able to take EKG to confirm)

    Time frame: bimonthly

  2. Free tiroxina and TSH (assessed by investigator other than treatment physician)

    Time frame: bimonthly

  3. Changes in EKG

    Time frame: baseline, at six months, or as needed

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de Nuevo Leon

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jun 16, 2009
Registry last updated
Jun 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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