Subclinical Hypothyroidism and Mind in the Elderly

NCT00921050 | Completed Phase 2 DMC

• 1 other identifier: EN_LC_P136
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Subclinical Hypothyroidism

Keywords

subclinical hypothyroidism; elderly; mild cognitive impairment; neuropsychological test; NEUROPSI

Outcome Measures

Primary Outcomes (3)

• Change in cognitive ability measured by NEUROPSI increase of 10 points

  baseline and after 6 months of treatment

• ejection fraction, left ventricular diastolic capacity

  baseline, after six months of treatment

• Lipid profile and body composition by DEXA

  baseline, after six months of treatment

Secondary Outcomes (3)

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

  bimonthly

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

  bimonthly

• Changes in EKG

  baseline, at six months, or as needed

Study Arms (2)

Levothyroxine

EXPERIMENTAL

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

Drug: levothyroxine sodium

Placebo

PLACEBO COMPARATOR

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

Drug: excipient without levothyroxine (placebo)

Interventions

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.

Also known as: eutirox (Merck), synthroid

Levothyroxine

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.

Also known as: sugar pills

Placebo

Eligibility Criteria

• Age: 60 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• TSH between 4 and 10 mUI/L inclusive

You may not qualify if:

• Known and treatment of thyroideal disease
• Arrythmia
• Anticoagulant treatment
• Dementia
• Disease leading to dementia (acv, LIVER....)

Sponsors & Collaborators

• Universidad Autonoma de Nuevo Leon: lead

Study Sites (2)

Endocrinology, Outpatient Hospital Clinic

Monterrey, Nuevo León, 64460, Mexico

Location

Community Health Center (Fomerrey 19)

Monterrey, Nuevo León, Mexico

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Thyroxine; Excipients

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Pharmaceutical Vehicles; Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses

Study Officials

• Lilia Cardenas-Ibarra, M.D.

  Endocrinology, University Hospital, Universidad Autonoma de Nuevo Leon

  PRINCIPAL INVESTIGATOR

• Jesus Z Villarreal-Perez, M.D.

  Endocrinology, University Hospital, Universidad Autonoma de Nuevo Leon

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 15, 2009
• First Posted: June 16, 2009
• Study Start: June 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: June 28, 2012

Record last verified: 2010-06

Locations

ME (2)