Clinical trial NCT03876704: Effects of Fat-soluble Vitamins Supplementation on Common Complications and Neural Development in Very Low Birth Weight Infants
Official title: Effects of Fat-soluble Vitamins Supplementation in Early Life on Common Complications and Neural Development in Very Low Birth Weight Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Vitamin A Deficiency
Vitamin D Deficiency
Vitamin E Deficiency
Very Low Birth Weight Infants
Bronchopulmonary Dysplasia
Anemia
Sepsis
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Xi'an Gaoxin Hospital
First posted: 2019-03-15
Enrollment: 120
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Vitamin levels
timeFrame: within 72 hours after birth, 4~6 weeks old
Secondary outcomes:
measure: Complications
timeFrame: corrected age of 36 weeks
measure: Neural development
timeFrame: corrected age of 40 weeks
measure: Gene polymorphism in vitamin deficiency preterm infants
timeFrame: within 72 hours after birth, 4~6 weeks old
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xian JiaotongUniversity
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital of Xian JiaotongUniversity
name: Shuang Liu
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.