Subclinical Hypothyroidism and Mind in the Elderly
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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 |
- 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 ]
- 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:
|
|
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 |
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| Mexico | |
| Community Health Center (Fomerrey 19) | |
| Monterrey, Nuevo Leon, Mexico | |
| Endocrinology, Outpatient Hospital Clinic | |
| Monterrey, Nuevo Leon, Mexico, 64460 | |
| 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 Thyroid Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013