Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-03-04 @ 10:12 PM
Study NCT ID:
NCT01235767
Status:
COMPLETED
Last Update Posted:
2020-11-24
First Post:
2010-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Animal Source Food Supplement and Pregnancy in Vietnam
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D001724', 'term': 'Birth Weight'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005502', 'term': 'Food'}], 'ancestors': [{'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 291}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-20', 'studyFirstSubmitDate': '2010-11-04', 'studyFirstSubmitQcDate': '2010-11-05', 'lastUpdatePostDateStruct': {'date': '2020-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Birth Weight', 'timeFrame': 'At birth', 'description': 'Weight of baby at birth on a scale weighing to 0.1 g made within one hour of delivery'}], 'secondaryOutcomes': [{'measure': 'Preterm birth', 'timeFrame': 'At birth', 'description': "Birth of baby prior to 37 weeks gestation based on mother's last menstrual period, confirmed by ultrasound"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['birth weight', 'prematurity', 'gestational age', 'low birth weight', 'pregnancy', 'nutrition', 'Vietnam'], 'conditions': ['Low Birth Weight', 'Preterm Birth']}, 'referencesModule': {'references': [{'pmid': '32584881', 'type': 'DERIVED', 'citation': 'Quyen PN, Nga HT, Chaffee B, Ngu T, King JC. Effect of maternal prenatal food supplementation, gestational weight gain, and breast-feeding on infant growth during the first 24 months of life in rural Vietnam. PLoS One. 2020 Jun 25;15(6):e0233671. doi: 10.1371/journal.pone.0233671. eCollection 2020.'}, {'pmid': '32469870', 'type': 'DERIVED', 'citation': 'Nga HT, Quyen PN, Chaffee BW, Diep Anh NT, Ngu T, King JC. Effect of a nutrient-rich, food-based supplement given to rural Vietnamese mothers prior to and/or during pregnancy on birth outcomes: A randomized controlled trial. PLoS One. 2020 May 29;15(5):e0232197. doi: 10.1371/journal.pone.0232197. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if a nutrient-rich supplement of animal-source foods ingested 5d/wk from pre-conception to term improves maternal nutrient status, decreases infections, and improves birth weight and rates of prematurity compared with supplemental ingestion during pregnancy ( from mid-gestation to term) or routine prenatal care.', 'detailedDescription': "It has been known for over 80 years that maternal starvation reduces fetal growth and increases neonatal infections. Many different nutrition programs have been targeted to pregnant women to improve pregnancy outcomes. The impact of these programs has been disappointing, and the prevalence of low birth weight (LBW) and infant mortality remains high, especially in developing countries. More recently, as a result of improved access to cereals following the 'green revolution,' nutritional concerns shifted from protein and energy to micronutrient deficiencies, especially those micronutrients in animal-source foods (ASFs)-iron, zinc, vitamins A and B12. Diets of pregnant women are usually limited to rice and a few vegetables, and they lack key nutrients known to reduce preterm delivery, to support fetal growth, and to prevent infections that leads to early neonatal deaths. Vietnam has a well-established farm system that supports the local production of fish, pork, poultry, and eggs. This provides an opportunity to evaluate the impact of a food-based, micronutrient-rich supplement on pregnancy outcome in high-risk, rural Vietnamese women. Since maternal nutritional status at conception is strongly linked to pregnancy outcomes, we will compare the effect of consuming a micronutrient-rich, animal-source food (ASF) supplement from pre-conception to term with a supplement from mid-gestation to term or routine prenatal care on infant birth weight, prematurity rate, and infant growth during the first 6 months of life. This study will be the first to compare a food-based, micronutrient-rich supplement consumed prior to conception to term with one given only during pregnancy. Although it is recognized by many that pregnancy may be too narrow a window to improve maternal nutritional health, it is typical for micronutrient supplements to only be given from the time of enrolling for prenatal care to term. The results of our study, therefore, will have world-wide implications regarding when maternal supplementation should be given to have the greatest impact on pregnancy outcome."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-pregnant women registering to marry in the Cam Khe District of Phu Tho Province\n* Nulliparous\n* Planning to reside in the study site for the next 3 years.\n\nExclusion Criteria:\n\n* Married\n* Have had a previous pregnancy\n* Have a history of severe infections (HIV, TB) or metabolic disease (diabetes)\n* BMI \\<17 kg/m2\n* Do not reside in study communes\n* Unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT01235767', 'acronym': 'VACVINA', 'briefTitle': 'Animal Source Food Supplement and Pregnancy in Vietnam', 'organization': {'class': 'OTHER', 'fullName': "UCSF Benioff Children's Hospital Oakland"}, 'officialTitle': 'Effect of Animal Source Food Supplement Prior to and During Pregnancy on Birth Weight and Prematurity in Rural Vietnam', 'orgStudyIdInfo': {'id': '2010-068'}, 'secondaryIdInfos': [{'id': 'TRF-01', 'type': 'OTHER_GRANT', 'domain': 'Thrasher Research Fund'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ASF supplement pre-pregnancy to term', 'description': 'Supplement of animal-source foods rich in iron, zinc, vitamin A, and vitamin B12', 'interventionNames': ['Other: Food']}, {'type': 'EXPERIMENTAL', 'label': 'ASF Supplement mid-gestation to term', 'description': 'Supplement of animal-source foods rich in iron, zinc, vitamin A, and vitamin B12', 'interventionNames': ['Other: Food']}, {'type': 'NO_INTERVENTION', 'label': 'Routine prenatal care', 'description': 'Nutrition education and iron-folate supplements during pregnancy'}], 'interventions': [{'name': 'Food', 'type': 'OTHER', 'description': 'Animal-source food (ASF) supplement rich in iron, zinc, vitamin A, and vitamin B12 taken week-days at mid-morning separate from other food. Length of intervention is either from pre-pregnancy (time of registration to marry) to term or from 16 weeks gestation to term.', 'armGroupLabels': ['ASF Supplement mid-gestation to term', 'ASF supplement pre-pregnancy to term']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hanoi', 'country': 'Vietnam', 'facility': 'National Institute of Nutrition', 'geoPoint': {'lat': 21.0245, 'lon': 105.84117}}], 'overallOfficials': [{'name': 'Janet C King, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "UCSF Benioff Children's Hospital Oakland"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "UCSF Benioff Children's Hospital Oakland", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}