Ignite Creation Date:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2025-12-24 @ 4:38 PM
Study NCT ID:
NCT04002466
Status:
COMPLETED
Last Update Posted:
2020-07-28
First Post:
2019-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anemia Etiology Evaluation in Ethiopia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012307', 'term': 'Risk Factors'}], 'ancestors': [{'id': 'D012306', 'term': 'Risk'}, {'id': 'D011336', 'term': 'Probability'}, {'id': 'D013223', 'term': 'Statistics as Topic'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D015984', 'term': 'Causality'}, {'id': 'D015981', 'term': 'Epidemiologic Factors'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5114}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-27', 'studyFirstSubmitDate': '2019-06-21', 'studyFirstSubmitQcDate': '2019-06-27', 'lastUpdatePostDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anemia', 'timeFrame': 'One day', 'description': 'Hemoglobin concentration by sex and age (\\<11 g/dL for children; Hb \\<12 g/dL for non-pregnant adult women, \\<13 g/dL for adult men). Hemoglobin concentrations will be adjusted for altitude and smoking status.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anemia']}, 'referencesModule': {'references': [{'pmid': '31651278', 'type': 'DERIVED', 'citation': 'Tadesse AW, Hemler EC, Andersen C, Passarelli S, Worku A, Sudfeld CR, Berhane Y, Fawzi WW. Anemia prevalence and etiology among women, men, and children in Ethiopia: a study protocol for a national population-based survey. BMC Public Health. 2019 Oct 24;19(1):1369. doi: 10.1186/s12889-019-7647-7.'}]}, 'descriptionModule': {'briefSummary': 'The AnemEE study is a population-based anemia etiology survey in six regions of Ethiopia. The primary aim of the study is to evaluate the relative contribution of risk factors for anemia among children, women of reproductive age, and adult men. The study data are intended to inform evidence-based decision-making on anemia control interventions.', 'detailedDescription': "The AnemEE study is a population-based cross-sectional survey of children (6-59 months), adult women of reproductive age (15-49 years) and adult males (15-49 years) in six regions of Ethiopia (Afar, Amhara, Tigray, Oromia, Southern Nations, Nationalities and Peoples' Region and Addis Ababa). The study will enroll approximately 5,100 participants and will be conducted in two survey rounds; one survey round in the Belg season and one survey round in the Meher season. All participants will have hemoglobin assessed and will have standardized questionnaires administered to assess sociodemographic, diet, morbidity, and other health/nutrition factors. All participants will also have assessments of anthropometric measures, malaria, and soil transmitted helminth infection. A subset of participants will also have serum ferritin, CRP, AGP, vitamin B12, and folate concentrations assessed. The study data will be used to determine the relative contributions of risk factors for anemia."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '48 Years', 'minimumAge': '6 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children (6-59 months); Women of reproductive age (15-49 years); Adult men (15-49 years)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women of reproductive age\n\n * Female living in a selected household that has a woman 15-49 years of age\n * Aged 15-49 years\n2. Adult Men\n\n * Male living in a selected household that has a woman 15-49 years of age\n * Aged 15-49 years\n3. Children\n\n * Male or female child living in a selected household that has a woman 15-49 years of age\n * Aged 6-59 months\n\nExclusion Criteria:\n\n* Does not provide informed consent'}, 'identificationModule': {'nctId': 'NCT04002466', 'acronym': 'AnemEE', 'briefTitle': 'Anemia Etiology Evaluation in Ethiopia', 'organization': {'class': 'OTHER', 'fullName': 'Harvard School of Public Health (HSPH)'}, 'officialTitle': 'Evaluation of Dietary Iron Intake, Anemia, and Iron Status Among Men, Women, and Children in Ethiopia', 'orgStudyIdInfo': {'id': 'OPP1179606'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children (6-59 months)', 'interventionNames': ['Other: Risk factors for anemia']}, {'label': 'Women of Reproductive Age (15-49 years)', 'interventionNames': ['Other: Risk factors for anemia']}, {'label': 'Adult Men (15-49 years)', 'interventionNames': ['Other: Risk factors for anemia']}], 'interventions': [{'name': 'Risk factors for anemia', 'type': 'OTHER', 'description': 'Diet, iron, vitamin B12, folate, inflammation, soil transmitted helminth infection, malaria, other morbidities and other health/nutrition/sociodemographic factors', 'armGroupLabels': ['Adult Men (15-49 years)', 'Children (6-59 months)', 'Women of Reproductive Age (15-49 years)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Addis Ababa', 'country': 'Ethiopia', 'facility': 'Addis Continental Institute of Public Health', 'geoPoint': {'lat': 9.02497, 'lon': 38.74689}}], 'overallOfficials': [{'name': 'Wafaie W Fawzi, MBBS, DrPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard School of Public Health (HSPH)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harvard School of Public Health (HSPH)', 'class': 'OTHER'}, 'collaborators': [{'name': 'Addis Continental Institute of Public Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Nutrition, Epidemiology, and Global Health', 'investigatorFullName': 'Wafaie Fawzi', 'investigatorAffiliation': 'Harvard School of Public Health (HSPH)'}}}}