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

First Affiliated Hospital Xi'an Jiaotong University120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Vitamin A Deficiency Vitamin D Deficiency

Eligibility

Sex: ALLMax age: 24 Hours

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Vitamin levels

Change from baseline level of vitamin A, vitamin D, and vitamin E at 4\~6 weeks

Time frame: within 72 hours after birth, 4~6 weeks old

Secondary Outcomes

Complications

The prevalence of bronchopulmonary dysplasia, patent ductus arteriosus, sepsis, anemia, intracranial hemorrhage, extrauterine growth retardation, etc.

Time frame: corrected age of 36 weeks

Neural development

White matter disease of the preterm infant, was semiquantitatively assessed from MRI at term-equivalent age based on an established scoring method.

Time frame: corrected age of 40 weeks

Gene polymorphism in vitamin deficiency preterm infants

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