Subclinical Hypothyroidism and Mind in the Elderly

Overview

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 Title of Study: “Randomized Double Blind Levothyroxine vs Placebo, Mind (NEUROPSI) Improvement in Elderly With Persistent TSH 4-10 mUI/L”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: March 2012

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

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Levothyroxine
    • Half of participants randomly assigned, take a pill daily, bimonthly thyroid test
  • Placebo Comparator: Placebo
    • Half of participants randomly assigned, take a pill daily, bimonthly thyroid test

Clinical Trial Outcome Measures

Primary Measures

  • Change in cognitive ability measured by NEUROPSI increase of 10 points
    • Time Frame: baseline and after 6 months of treatment
  • ejection fraction, left ventricular diastolic capacity
    • Time Frame: baseline, after six months of treatment
  • Lipid profile and body composition by DEXA
    • Time Frame: baseline, after six months of treatment

Secondary Measures

  • clinical assessment v.g. significant changes in cardiac frequency and rhythm (if needed able to take EKG to confirm)
    • Time Frame: bimonthly
  • Free tiroxina and TSH (assessed by investigator other than treatment physician)
    • Time Frame: bimonthly
  • Changes in EKG
    • Time Frame: baseline, at six months, or as needed

Participating in This Clinical Trial

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….)

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: 95 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universidad Autonoma de Nuevo Leon
  • Provider of Information About this Clinical Study
    • Principal Investigator: Lilia Csrdenas-Ibarra, MD – Universidad Autonoma de Nuevo Leon
  • Overall Official(s)
    • Lilia Cardenas-Ibarra, M.D., Principal Investigator, Endocrinology, University Hospital, Universidad Autonoma de Nuevo Leon
    • Jesus Z Villarreal-Perez, M.D., Study Chair, Endocrinology, University Hospital, Universidad Autonoma de Nuevo Leon

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