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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013974', 'term': 'Thyroxine'}, {'id': 'D005079', 'term': 'Excipients'}], 'ancestors': [{'id': 'D013963', 'term': 'Thyroid Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014677', 'term': 'Pharmaceutical Vehicles'}, {'id': 'D010592', 'term': 'Pharmaceutic Aids'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-27', 'studyFirstSubmitDate': '2009-06-15', 'studyFirstSubmitQcDate': '2009-06-15', 'lastUpdatePostDateStruct': {'date': '2012-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in cognitive ability measured by NEUROPSI increase of 10 points', 'timeFrame': 'baseline and after 6 months of treatment'}, {'measure': 'ejection fraction, left ventricular diastolic capacity', 'timeFrame': 'baseline, after six months of treatment'}, {'measure': 'Lipid profile and body composition by DEXA', 'timeFrame': 'baseline, after six months of treatment'}], 'secondaryOutcomes': [{'measure': 'clinical assessment v.g. significant changes in cardiac frequency and rhythm (if needed able to take EKG to confirm)', 'timeFrame': 'bimonthly'}, {'measure': 'Free tiroxina and TSH (assessed by investigator other than treatment physician)', 'timeFrame': 'bimonthly'}, {'measure': 'Changes in EKG', 'timeFrame': 'baseline, at six months, or as needed'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['subclinical hypothyroidism', 'elderly', 'mild cognitive impairment', 'neuropsychological test', 'NEUROPSI'], 'conditions': ['Subclinical Hypothyroidism']}, 'descriptionModule': {'briefSummary': '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…).\n\nThe 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.\n\nNEUROPSI is a validated neuropsychological test sensible for mild cognitive alterations. It can be applied to individuals with little schooling.\n\nThis 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.', 'detailedDescription': '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.\n\nThe protocol original dates changed as follows:\n\n* Restart screening June 20 to end in August 2009;\n* Enrolling start at the end of June (the already identified);\n* End enrolling October 2009;\n* Follow up will end in May 2010.\n\nNote: 150 of the screened subjects will be from randomly selected homes at Fomerrey 19 to allow prevalence estimation.\n\n* Enroling ended until june 2010\n* Follow up stil ungoing final measures will be done at the end of 2011'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* TSH between 4 and 10 mUI/L inclusive\n\nExclusion Criteria:\n\n* Known and treatment of thyroideal disease\n* Arrythmia\n* Anticoagulant treatment\n* Dementia\n* Disease leading to dementia (acv, LIVER....)'}, 'identificationModule': {'nctId': 'NCT00921050', 'briefTitle': 'Subclinical Hypothyroidism and Mind in the Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Autonoma de Nuevo Leon'}, 'officialTitle': 'Randomized Double Blind Levothyroxine vs Placebo, Mind (NEUROPSI) Improvement in Elderly With Persistent TSH 4-10 mUI/L', 'orgStudyIdInfo': {'id': 'EN_LC_P136'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Levothyroxine', 'description': 'Half of participants randomly assigned, take a pill daily, bimonthly thyroid test', 'interventionNames': ['Drug: levothyroxine sodium']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Half of participants randomly assigned, take a pill daily, bimonthly thyroid test', 'interventionNames': ['Drug: excipient without levothyroxine (placebo)']}], 'interventions': [{'name': 'levothyroxine sodium', 'type': 'DRUG', 'otherNames': ['eutirox (Merck)', 'synthroid'], 'description': '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.', 'armGroupLabels': ['Levothyroxine']}, {'name': 'excipient without levothyroxine (placebo)', 'type': 'DRUG', 'otherNames': ['sugar pills'], 'description': '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.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64460', 'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Endocrinology, Outpatient Hospital Clinic', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Community Health Center (Fomerrey 19)', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}], 'overallOfficials': [{'name': 'Lilia Cardenas-Ibarra, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Endocrinology, University Hospital, Universidad Autonoma de Nuevo Leon'}, {'name': 'Jesus Z Villarreal-Perez, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Endocrinology, University Hospital, Universidad Autonoma de Nuevo Leon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Autonoma de Nuevo Leon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Lilia Csrdenas-Ibarra', 'investigatorAffiliation': 'Universidad Autonoma de Nuevo Leon'}}}}