Subclinical Hypothyroidism and Mind in the Elderly

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lilia Csrdenas-Ibarra, Universidad Autonoma de Nuevo Leon
ClinicalTrials.gov Identifier:
NCT00921050
First received: June 15, 2009
Last updated: June 27, 2012
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Subclinical Hypothyroidism
Drug: levothyroxine sodium
Drug: excipient without levothyroxine (placebo)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Double Blind Levothyroxine vs Placebo, Mind (NEUROPSI) Improvement in Elderly With Persistent TSH 4-10 mUI/L

Resource links provided by NLM:


Further study details as provided by Universidad Autonoma de Nuevo Leon:

Primary Outcome Measures:
  • Change in cognitive ability measured by NEUROPSI increase of 10 points [ Time Frame: baseline and after 6 months of treatment ] [ Designated as safety issue: No ]
  • ejection fraction, left ventricular diastolic capacity [ Time Frame: baseline, after six months of treatment ] [ Designated as safety issue: No ]
  • Lipid profile and body composition by DEXA [ Time Frame: baseline, after six months of treatment ] [ Designated as safety issue: No ]

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

Enrollment: 70
Study Start Date: June 2009
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levothyroxine
Half of participants randomly assigned, take a pill daily, bimonthly thyroid test
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.
Other Names:
  • eutirox (Merck)
  • synthroid
Placebo Comparator: Placebo
Half of participants randomly assigned, take a pill daily, bimonthly thyroid test
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.
Other Name: sugar pills

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
  Eligibility

Ages Eligible for Study:   60 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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....)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00921050

Locations
Mexico
Community Health Center (Fomerrey 19)
Monterrey, Nuevo Leon, Mexico
Endocrinology, Outpatient Hospital Clinic
Monterrey, Nuevo Leon, Mexico, 64460
Sponsors and Collaborators
Universidad Autonoma de Nuevo Leon
Investigators
Principal Investigator: Lilia Cardenas-Ibarra, M.D. Endocrinology, University Hospital, Universidad Autonoma de Nuevo Leon
Study Chair: Jesus Z Villarreal-Perez, M.D. Endocrinology, University Hospital, Universidad Autonoma de Nuevo Leon
  More Information

No publications provided

Responsible Party: Lilia Csrdenas-Ibarra, MD, Universidad Autonoma de Nuevo Leon
ClinicalTrials.gov Identifier: NCT00921050     History of Changes
Other Study ID Numbers: EN_LC_P136
Study First Received: June 15, 2009
Last Updated: June 27, 2012
Health Authority: Mexico: Ministry of Health

Keywords provided by Universidad Autonoma de Nuevo Leon:
subclinical hypothyroidism
elderly
mild cognitive impairment
neuropsychological test
NEUROPSI

Additional relevant MeSH terms:
Hypothyroidism
Endocrine System Diseases
Thyroid Diseases

ClinicalTrials.gov processed this record on October 22, 2014