Effects of Fat-soluble Vitamins Supplementation on Common Complications and Neural Development in Very Low Birth Weight Infants
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: High dose of fat-soluble vitamins 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. |
Drug: High dose of fat-Soluble Vitamin
Supplementation of 5 times current dose of fat-soluble vitamins by intravenous perfusion
|
| Active Comparator: Conventional dose of fat-soluble vitamins 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. |
Drug: Conventional dose of fat-Soluble Vitamin
Supplementation of the current dose of fat-soluble vitamins by intravenous perfusion
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | First Affiliated Hospital of Xian JiaotongUniversity | Xi'an | Shaanxi | China | 710061 |
Sponsors and Collaborators
- First Affiliated Hospital Xi'an Jiaotong University
- Xi'an Gaoxin Hospital
Investigators
- Study Director: Shuang Liu, First Affiliated Hospital of Xian JiaotongUniversity
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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. Review.
- 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.
- 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.
- 2018MSZC-04