Effects of Fat-soluble Vitamins Supplementation on Common Complications and Neural Development in Very Low Birth Weight Infants

Phase 3

• Conditions: Very Low Birth Weight Infants; Bronchopulmonary Dysplasia; Vitamin E Deficiency; Anemia; Sepsis; Vitamin A Deficiency; Vitamin D Deficiency
• Interventions: Drug: High dose of fat-Soluble Vitamin; Drug: Conventional dose of fat-Soluble Vitamin

• Registration Number: NCT03876704
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-29
• Status Verified: 2019-02
• Study First Submitted: 2019-03-03
• Study First Submitted QC: 2019-03-13
• Last Update Submitted: 2019-03-13
• Study First Posted: 2019-03-15
• Last Update Posted: 2019-03-15
• Primary Completion: 2019-09-30
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• admitted to the neonatal intensive care unit (NICU) within 24 hours after birth
• gestational age younger than 34 weeks
• birth weight less than 1500 gram
• informed consent was obtained from the infants' parents or guardians

Exclusion Criteria

• congenital malformation
• chromosomal disease, genetic metabolic diseases
• the infants or his/mother has abnormal thyroid function or parathyroid gland function
• neonatal necrotizing enterocolitis, diarrhea
• intracranial hemorrhage of 3 degrees or above
• pulmonary hemorrhage
• liver enzymes elevated by more than 2 times, cholestasis
• death or discharge against medical advice
• refuse to take part in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose of fat-soluble vitamins	High dose of fat-Soluble Vitamin	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.
Conventional dose of fat-soluble vitamins	Conventional dose of fat-Soluble Vitamin	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.

Primary Outcome Measures

Name	Time	Method
Vitamin levels	within 72 hours after birth, 4~6 weeks old	Change from baseline level of vitamin A, vitamin D, and vitamin E at 4\~6 weeks

Secondary Outcome Measures

Name	Time	Method
Complications	corrected age of 36 weeks	The prevalence of bronchopulmonary dysplasia, patent ductus arteriosus, sepsis, anemia, intracranial hemorrhage, extrauterine growth retardation, etc.
Neural development	corrected age of 40 weeks	White matter disease of the preterm infant, was semiquantitatively assessed from MRI at term-equivalent age based on an established scoring method.
Gene polymorphism in vitamin deficiency preterm infants	within 72 hours after birth, 4~6 weeks old	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

Trial Locations

Locations (1)

First Affiliated Hospital of Xian JiaotongUniversity; 🇨🇳 Xi'an, Shaanxi, China