Subclinical HypothyroidismPhase 2/3NCT00921050
Subclinical Hypothyroidism and Mind in the Elderly
A Phase 2/3 study testing levothyroxine sodium in people with Subclinical Hypothyroidism, run by Universidad Autonoma de Nuevo Leon at 2 sites in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 95 years
- Conditions the study is for
- Subclinical Hypothyroidism
- What is being tested?
- levothyroxine sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 2 sitesMexico
- Study dates
- Jun 2009to Mar 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- TSH between 4 and 10 mUI/L inclusive
Who cannot join
- Known and treatment of thyroideal disease
- Arrythmia
- Anticoagulant treatment
- Dementia
- Disease leading to dementia (acv, LIVER....)
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites
Endocrinology, Outpatient Hospital Clinic
Monterrey, Nuevo León, 64460
Community Health Center (Fomerrey 19)
Monterrey, Nuevo León
About this study
Official title: Randomized Double Blind Levothyroxine vs Placebo, Mind (NEUROPSI) Improvement in Elderly With Persistent TSH 4-10 mUI/L
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.
Read more
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.
Read the 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
- Conditions
- Subclinical Hypothyroidism
- Being tested
- levothyroxine sodium, excipient without levothyroxine (placebo)
- Keywords
- subclinical hypothyroidism, elderly, mild cognitive impairment, neuropsychological test, NEUROPSI
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levothyroxine sodiumDrug
Also called eutirox (Merck), synthroid
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.
excipient without levothyroxine (placebo)Drug
Also called sugar pills
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.
| Study group | Role | What they receive |
|---|---|---|
| Levothyroxine | Experimental | Half of participants randomly assigned, take a pill daily, bimonthly thyroid test Receives: Drug: levothyroxine sodium |
| Placebo | Placebo comparator | Half of participants randomly assigned, take a pill daily, bimonthly thyroid test Receives: Drug: excipient without levothyroxine (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive ability measured by NEUROPSI increase of 10 points
Measured: baseline and after 6 months of treatment
ejection fraction, left ventricular diastolic capacity
Measured: baseline, after six months of treatment
Lipid profile and body composition by DEXA
Measured: 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)
Measured: bimonthly
Free tiroxina and TSH (assessed by investigator other than treatment physician)
Measured: bimonthly
Changes in EKG
Measured: baseline, at six months, or as needed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subclinical HypothyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Nuevo Leon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lilia Csrdenas-Ibarra, Universidad Autonoma de Nuevo Leon
- Investigators
- Lilia Cardenas-Ibarra, M.D., Principal investigator, Endocrinology, University Hospital, Universidad Autonoma de Nuevo LeonJesus Z Villarreal-Perez, M.D., Study chair, Endocrinology, University Hospital, Universidad Autonoma de Nuevo Leon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921050
- Sponsor's protocol ID
- EN_LC_P136
- Status last verified
- Jun 2010
- First submitted
- 15 Jun 2009
- Last updated
- 28 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Levothyroxine vs Placebo, Mind (NEUROPSI) Improvement in Elderly With Persistent TSH 4-10 mUI/L
- ClinicalTrials.gov ID
- NCT00921050
- Acronym / sponsor ID
- EN_LC_P136
- Conditions
- Subclinical Hypothyroidism
- Keywords
- subclinical hypothyroidism, elderly, mild cognitive impairment, neuropsychological test, NEUROPSI
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Universidad Autonoma de Nuevo LeonUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 16 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levothyroxine | Experimental | Drug: levothyroxine sodiumHalf of participants randomly assigned, take a pill daily, bimonthly thyroid test |
| Placebo | Placebo comparator | Drug: excipient without levothyroxine (placebo)Half of participants randomly assigned, take a pill daily, bimonthly thyroid test |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- TSH between 4 and 10 mUI/L inclusive
Key exclusion criteria (5 listed)
- Known and treatment of thyroideal disease
- Arrythmia
- Anticoagulant treatment
- Dementia
- Disease leading to dementia (acv, LIVER....)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levothyroxine sodiumAlso: eutirox (Merck), synthroidDaily 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 | Levothyroxine |
| excipient without levothyroxine (placebo)Also: sugar pillsDaily 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. | Drug | Placebo |
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing levothyroxine sodium in people with Subclinical Hypothyroidism, run by Universidad Autonoma de Nuevo Leon at 2 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive ability measured by NEUROPSI increase of 10 points (time frame: baseline and after 6 months of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2012; AzTrials last refreshed its copy on 6 Nov 2026.