Ignite Creation Date:
2025-12-24 @ 6:34 PM
Ignite Modification Date:
2025-12-27 @ 5:27 PM
Study NCT ID:
NCT00128557
Status:
COMPLETED
Last Update Posted:
2022-10-03
First Post:
2005-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Community Trial of Newborn Vitamin A Supplementation to Reduce Infant Mortality in Rural Bangladesh
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014802', 'term': 'Vitamin A Deficiency'}, {'id': 'D066088', 'term': 'Infant Death'}], 'ancestors': [{'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15937}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-28', 'studyFirstSubmitDate': '2005-08-09', 'studyFirstSubmitQcDate': '2005-08-09', 'lastUpdatePostDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '24-week infant mortality rate'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Vitamin A', 'Newborn health', 'Infant Mortality', 'Supplementation', 'Micronutrients', 'Bangladesh'], 'conditions': ['Mortality Through Six Months of Age', 'Vitamin A Deficiency']}, 'referencesModule': {'references': [{'pmid': '28490513', 'type': 'DERIVED', 'citation': 'Ali H, Hamadani J, Mehra S, Tofail F, Hasan MI, Shaikh S, Shamim AA, Wu LS, West KP Jr, Christian P. Effect of maternal antenatal and newborn supplementation with vitamin A on cognitive development of school-aged children in rural Bangladesh: a follow-up of a placebo-controlled, randomized trial. Am J Clin Nutr. 2017 Jul;106(1):77-87. doi: 10.3945/ajcn.116.134478. Epub 2017 May 10.'}, {'pmid': '21832026', 'type': 'DERIVED', 'citation': 'Coles CL, Labrique A, Saha SK, Ali H, Al-Emran H, Rashid M, Christian P, West KP Jr, Klemm R. Newborn vitamin A supplementation does not affect nasopharyngeal carriage of Streptococcus pneumoniae in Bangladeshi infants at age 3 months. J Nutr. 2011 Oct;141(10):1907-11. doi: 10.3945/jn.111.141622. Epub 2011 Aug 10.'}], 'seeAlsoLinks': [{'url': 'http://www.jhsph.edu/chn/Research/micronutrients.html', 'label': 'Micronutrient research at the Center for Human Nutrition at Johns Hopkins Bloomberg School of Public Health)'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is determine whether a 50,000 IU oral dose of vitamin A delivered to newborn infants within the first days of life, reduces six-month infant mortality by at least 15%. The trial will also evaluate whether the survival impact of newborn vitamin A dosing is modified by concurrent weekly, routine maternal vitamin A or beta-carotene supplementation during pregnancy through three months postpartum, gestational age and birth size.', 'detailedDescription': 'This is a randomized, double-masked, placebo-controlled, community trial of newborn vitamin A supplementation on mortality in the first six months of life. The trial is being implemented in 596 sectors (i.e. villages and/or smaller groupings), in two thanas comprising a population of \\~580,000 in rural northern Bangladesh (Gaibandha/Rangpur area) and is nested within the JiVitA-1 maternal supplementation study. Women residing in the study area are already under 5-weekly pregnancy surveillance conducted by village-based field staff as part of the maternal supplementation trial. During their third trimester of pregnancy, women are visited by a study supervisor who explains the purpose and procedures of the study. After obtaining informed consent, women are interviewed for possible risk factors in the third trimester of pregnancy, including a 30-day history of morbidity, a 7-day dietary and alcohol intake and tobacco use questionnaire, a 7-day household chores questionnaire, and maternal anthropometry (mid upper arm circumference measurement). Upon birth, household members contact the village-based field staff who immediately administers the vitamin A or placebo to the infant, according to sector assignment. After supplementation, newborns are measured for weight, length and mid-upper arm, head and chest circumference, and then followed weekly for vital status for three months, and again at six months of age. A child death initiates the process of death verification and cause of death determination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '30 Days', 'minimumAge': '1 Minute', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: Infants born to women enrolled in a maternal supplementation trial, alive and less than 30 days of age during a newborn dosing visit Exclusion Criteria: Infants who died before the dose could be administered or infants older than 30 days at the time of dosing'}, 'identificationModule': {'nctId': 'NCT00128557', 'briefTitle': 'Community Trial of Newborn Vitamin A Supplementation to Reduce Infant Mortality in Rural Bangladesh', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins Bloomberg School of Public Health'}, 'officialTitle': 'A Randomized Community Trial of Newborn Vitamin A Supplementation to Reduce Infant Mortality in Rural Bangladesh', 'orgStudyIdInfo': {'id': 'H.22.03.01.09.A2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Supplement containing soybean oil with a small amount of vitamin E as an antioxidant', 'interventionNames': ['Dietary Supplement: vitamin A supplementation (15,000 ug retinol equivalents or 50,000 IU)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin A', 'description': '15,000 ug retinol equivalents (50,000 International Units)', 'interventionNames': ['Dietary Supplement: vitamin A supplementation (15,000 ug retinol equivalents or 50,000 IU)']}], 'interventions': [{'name': 'vitamin A supplementation (15,000 ug retinol equivalents or 50,000 IU)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Single dose of 15,000 ug retinol equivalents at or near birth vs a placebo', 'armGroupLabels': ['Placebo', 'Vitamin A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rangpur', 'state': 'Rajshahi Division', 'country': 'Bangladesh', 'facility': 'JiVitA Bangladesh Project'}], 'overallOfficials': [{'name': 'Rolf DW Klemm, Dr PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}, {'name': 'Keith P West, Jr., Dr. P.H.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Johns Hopkins Bloomberg School of Public Health'}, {'name': 'Parul Christian, Dr. P.H.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Johns Hopkins Bloomberg School of Public Health'}, {'name': 'Mahbubar Rashid, MBBS, MSc, MBA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'JiVitA Bangladesh Project'}, {'name': 'Alain B. Labrique, MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Johns Hopkins Bloomberg School of Public Health'}, {'name': 'Alfred Sommer, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Johns Hopkins Bloomberg School of Public Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins Bloomberg School of Public Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Agency for International Development (USAID)', 'class': 'FED'}, {'name': 'Johns Hopkins University', 'class': 'OTHER'}, {'name': 'Bill and Melinda Gates Foundation', 'class': 'OTHER'}, {'name': 'Canadian International Development Agency', 'class': 'OTHER_GOV'}, {'name': 'Access Business Group', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}