Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT00283660
Status:
COMPLETED
Last Update Posted:
2015-11-17
First Post:
2006-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Zinc, Mental Health, and School Performance in Guatemalan Schoolchildren
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Mexico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015034', 'term': 'Zinc Oxide'}], 'ancestors': [{'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017967', 'term': 'Zinc Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 750}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-16', 'studyFirstSubmitDate': '2006-01-26', 'studyFirstSubmitQcDate': '2006-01-26', 'lastUpdatePostDateStruct': {'date': '2015-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptoms of depression', 'timeFrame': 'Baseline and post supplementation'}], 'secondaryOutcomes': [{'measure': 'Symptoms of anxiety', 'timeFrame': 'Baseline and post supplementation'}, {'measure': 'attention problems and school performance', 'timeFrame': 'Baseline and post supplementation'}, {'measure': 'activity levels', 'timeFrame': 'Baseline and post supplementation'}, {'measure': 'zinc levels', 'timeFrame': 'Baseline and post supplementation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Zinc', 'Dietary Supplements', 'Nutritional Supplements', 'Child', 'Mental Health', 'School', 'Guatemala'], 'conditions': ['Depression', 'Anxiety']}, 'referencesModule': {'references': [{'pmid': '20881069', 'type': 'RESULT', 'citation': 'DiGirolamo AM, Ramirez-Zea M, Wang M, Flores-Ayala R, Martorell R, Neufeld LM, Ramakrishnan U, Sellen D, Black MM, Stein AD. Randomized trial of the effect of zinc supplementation on the mental health of school-age children in Guatemala. Am J Clin Nutr. 2010 Nov;92(5):1241-50. doi: 10.3945/ajcn.2010.29686. Epub 2010 Sep 29.'}, {'pmid': '22354676', 'type': 'RESULT', 'citation': 'Bui VQ, Stein AD, DiGirolamo AM, Ramakrishnan U, Flores-Ayala RC, Ramirez-Zea M, Grant FK, Villalpando S, Martorell R. Associations between serum C-reactive protein and serum zinc, ferritin, and copper in Guatemalan school children. Biol Trace Elem Res. 2012 Aug;148(2):154-60. doi: 10.1007/s12011-012-9358-0. Epub 2012 Feb 22.'}]}, 'descriptionModule': {'briefSummary': 'This study will determine whether supplements of the mineral zinc will improve mental health and school performance among schoolchildren in Guatemala.', 'detailedDescription': "Mental health problems are an important cause of dysfunction throughout the world, accounting for 8.1% of the Global Burden of Disease. The need for interventions that can prevent mental health conditions, particularly among children, cannot be overemphasized. This study will determine whether zinc supplementation improves the mental health and school performance among children in Guatemala.\n\nParticipants will be randomly assigned to receive daily supplements of either zinc or placebo for 6 months. Participants will be assessed at study entry and after the 6-month treatment. Participants and their parents and teachers will complete questionnaires about the participants' symptoms of depression and anxiety, concentration and activity levels, school performance, and any environmental stressors to which the participants may be exposed to."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Attend a public school in specific Guatemalan community and has thorough and up-to-date school records\n* Currently in 2nd to 6th grade\n* Parent or guardian willing to provide informed consent\n\nExclusion Criteria:\n\n* Any illness that may affect participants' zinc levels\n* Any chronic illness\n* History of cancer"}, 'identificationModule': {'nctId': 'NCT00283660', 'briefTitle': 'Zinc, Mental Health, and School Performance in Guatemalan Schoolchildren', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Zinc, Mental Health, and School Performance', 'orgStudyIdInfo': {'id': 'IRB00045755'}, 'secondaryIdInfos': [{'id': 'R01MH067981', 'link': 'https://reporter.nih.gov/quickSearch/R01MH067981', 'type': 'NIH'}, {'id': 'DSIR 84-CTM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active', 'description': 'Dietary Supplement: 10 mg zinc oxide', 'interventionNames': ['Dietary Supplement: 10 mg zinc oxide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo (double blinded)', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': '10 mg zinc oxide', 'type': 'DIETARY_SUPPLEMENT', 'description': '10 mg zinc oxide', 'armGroupLabels': ['Active']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo pill taken five days a week for six months.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01011', 'city': 'Guatemala City', 'country': 'Guatemala', 'facility': 'Instituto de Nutrición de Centro América y Panamá - INCAP', 'geoPoint': {'lat': 14.64072, 'lon': -90.51327}}], 'overallOfficials': [{'name': 'Aryeh D Stein, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'Institute of Nutrition of Central America and Panama (INCAP)', 'class': 'UNKNOWN'}, {'name': 'Mexican National Institute of Public Health', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Global Health', 'investigatorFullName': 'Aryeh David Stein', 'investigatorAffiliation': 'Emory University'}}}}