Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-29 @ 5:05 PM
Study NCT ID:
NCT00921050
Status:
COMPLETED
Last Update Posted:
2012-06-28
First Post:
2009-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Subclinical Hypothyroidism and Mind in the Elderly
Sponsor:
Universidad Autonoma de Nuevo Leon
Organization:
Study Overview
Official Title:
Randomized Double Blind Levothyroxine vs Placebo, Mind (NEUROPSI) Improvement in Elderly With Persistent TSH 4-10 mUI/L
Status:
COMPLETED
Status Verified Date:
2010-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: