Ignite Creation Date:
2025-12-24 @ 9:13 PM
Ignite Modification Date:
2026-01-22 @ 1:24 PM
Study NCT ID:
NCT03876704
Status:
UNKNOWN
Last Update Posted:
2019-03-15
First Post:
2019-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Fat-soluble Vitamins Supplementation on Common Complications and Neural Development in Very Low Birth Weight Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014802', 'term': 'Vitamin A Deficiency'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D014811', 'term': 'Vitamin E Deficiency'}, {'id': 'D001997', 'term': 'Bronchopulmonary Dysplasia'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D018805', 'term': 'Sepsis'}], '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': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'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', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-13', 'studyFirstSubmitDate': '2019-03-03', 'studyFirstSubmitQcDate': '2019-03-13', 'lastUpdatePostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vitamin levels', 'timeFrame': 'within 72 hours after birth, 4~6 weeks old', 'description': 'Change from baseline level of vitamin A, vitamin D, and vitamin E at 4\\~6 weeks'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': 'corrected age of 36 weeks', 'description': 'The prevalence of bronchopulmonary dysplasia, patent ductus arteriosus, sepsis, anemia, intracranial hemorrhage, extrauterine growth retardation, etc.'}, {'measure': 'Neural development', 'timeFrame': 'corrected age of 40 weeks', 'description': 'White matter disease of the preterm infant, was semiquantitatively assessed from MRI at term-equivalent age based on an established scoring method.'}, {'measure': 'Gene polymorphism in vitamin deficiency preterm infants', 'timeFrame': 'within 72 hours after birth, 4~6 weeks old', 'description': "Association of rs4588 polymorphism in vitamin D receptor gene and rs10766197 polymorphism in the cytochrome P450 family 2 subfamily R member 1 gene with baseline level of vitamin D and change in vitamin D level after 4\\~6 weeks' supplementation"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vitamin A Deficiency', 'Vitamin D Deficiency', 'Vitamin E Deficiency', 'Very Low Birth Weight Infants', 'Bronchopulmonary Dysplasia', 'Anemia', 'Sepsis']}, 'referencesModule': {'references': [{'pmid': '21233795', 'type': 'BACKGROUND', 'citation': 'Kositamongkol S, Suthutvoravut U, Chongviriyaphan N, Feungpean B, Nuntnarumit P. Vitamin A and E status in very low birth weight infants. J Perinatol. 2011 Jul;31(7):471-6. doi: 10.1038/jp.2010.155. Epub 2011 Jan 13.'}, {'pmid': '21242240', 'type': 'BACKGROUND', 'citation': 'Mactier H, Mokaya MM, Farrell L, Edwards CA. Vitamin A provision for preterm infants: are we meeting current guidelines? Arch Dis Child Fetal Neonatal Ed. 2011 Jul;96(4):F286-9. doi: 10.1136/adc.2010.190017. Epub 2011 Jan 17.'}, {'pmid': '30559825', 'type': 'BACKGROUND', 'citation': 'Jilani T, Iqbal MP. Vitamin E deficiency in South Asian population and the therapeutic use of alpha-tocopherol (Vitamin E) for correction of anemia. Pak J Med Sci. 2018 Nov-Dec;34(6):1571-1575. doi: 10.12669/pjms.346.15880.'}, {'pmid': '28472980', 'type': 'BACKGROUND', 'citation': 'Cho SY, Park HK, Lee HJ. Efficacy and safety of early supplementation with 800 IU of vitamin D in very preterm infants followed by underlying levels of vitamin D at birth. Ital J Pediatr. 2017 May 4;43(1):45. doi: 10.1186/s13052-017-0361-0.'}, {'pmid': '24289974', 'type': 'RESULT', 'citation': 'Fares S, Sethom MM, Khouaja-Mokrani C, Jabnoun S, Feki M, Kaabachi N. VitaminA, E, and D deficiencies in tunisian very low birth weight neonates: prevalence and risk factors. Pediatr Neonatol. 2014 Jun;55(3):196-201. doi: 10.1016/j.pedneo.2013.09.006. Epub 2013 Nov 26.'}]}, 'descriptionModule': {'briefSummary': 'Vitamins A, D, and E play important roles in humans, such as vision function, immune function, bone metabolism, cell growth and differentiation and oxidation resistance. Deficiencies in these vitamins will result in a high prevalence of cardiovascular disease, infection, bone diseases, etc. Preterm infants, especially very low birth weight infants, are at risk of vitamin deficiency. Intravenous perfusion is the most common and widely used method to supply vitamins for the specific population in early life. However, the current dose of vitamin supplied by intravenous perfusion whether can meet the need of growth and development is not sure and the appropriate dose for preterm infants is still uncertain. The purpose of this study is to investigate whether current dose of fat-soluble vitamin supplementation is enough for very low birth weight infants, the safety of high dose of fat-soluble vitamin supplementation, and compare the differences of prevalence of common complications, such as bronchopulmonary dysplasia, patent ductus arteriosus, sepsis, anemia, and neural development between these two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* admitted to the neonatal intensive care unit (NICU) within 24 hours after birth\n* gestational age younger than 34 weeks\n* birth weight less than 1500 gram\n* informed consent was obtained from the infants' parents or guardians\n\nExclusion Criteria:\n\n* congenital malformation\n* chromosomal disease, genetic metabolic diseases\n* the infants or his/mother has abnormal thyroid function or parathyroid gland function\n* neonatal necrotizing enterocolitis, diarrhea\n* intracranial hemorrhage of 3 degrees or above\n* pulmonary hemorrhage\n* liver enzymes elevated by more than 2 times, cholestasis\n* death or discharge against medical advice\n* refuse to take part in the study"}, 'identificationModule': {'nctId': 'NCT03876704', 'briefTitle': 'Effects of Fat-soluble Vitamins Supplementation on Common Complications and Neural Development in Very Low Birth Weight Infants', 'organization': {'class': 'OTHER', 'fullName': "First Affiliated Hospital Xi'an Jiaotong University"}, 'officialTitle': 'Effects of Fat-soluble Vitamins Supplementation in Early Life on Common Complications and Neural Development in Very Low Birth Weight Infants', 'orgStudyIdInfo': {'id': '2018MSZC-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High dose of fat-soluble vitamins', 'description': 'Fat-soluble vitamins is administered 0.5 piece/kg (equals to 1150 U/kg vitamin A，200 U/kg vitamin D, 3.2 U/kg vitamin E) intravenously every day until the baby achieve full enteral feeding (120 ml/kg), starting with the first dose within 24 hours after birth.', 'interventionNames': ['Drug: High dose of fat-Soluble Vitamin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional dose of fat-soluble vitamins', 'description': 'Fat-soluble vitamins is administered 0.1 piece/kg (equals to 230 U/kg vitamin A，40 U/kg vitamin D, 0.64 U/kg vitamin E) intravenously every day until the baby achieve full enteral feeding (120 ml/kg), starting with the first dose within 24 hours after birth.', 'interventionNames': ['Drug: Conventional dose of fat-Soluble Vitamin']}], 'interventions': [{'name': 'High dose of fat-Soluble Vitamin', 'type': 'DRUG', 'description': 'Supplementation of 5 times current dose of fat-soluble vitamins by intravenous perfusion', 'armGroupLabels': ['High dose of fat-soluble vitamins']}, {'name': 'Conventional dose of fat-Soluble Vitamin', 'type': 'DRUG', 'description': 'Supplementation of the current dose of fat-soluble vitamins by intravenous perfusion', 'armGroupLabels': ['Conventional dose of fat-soluble vitamins']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710061', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xihui Zhou', 'role': 'CONTACT'}], 'facility': 'First Affiliated Hospital of Xian JiaotongUniversity', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Shuang Liu', 'role': 'CONTACT', 'email': 'liushuangpku@126.com', 'phone': '008615201524806'}], 'overallOfficials': [{'name': 'Shuang Liu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'First Affiliated Hospital of Xian JiaotongUniversity'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First Affiliated Hospital Xi'an Jiaotong University", 'class': 'OTHER'}, 'collaborators': [{'name': "Xi'an Gaoxin Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}