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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03876704
• Other study ID #: 2018MSZC-04
• Status: Recruiting
• Phase: Phase 3
• Start date: January 29, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2019
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Shuang Liu
• Phone: 008615201524806
• Email: liushuangpku[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2020
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Hours

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Birth Weight
• Body Weight
• Bronchopulmonary Dysplasia
• Night Blindness
• Sepsis
• Very Low Birth Weight Infants
• Vitamin A Deficiency
• Vitamin D Deficiency
• Vitamin E Deficiency

Intervention

Drug:
• High dose of fat-Soluble Vitamin
Supplementation of 5 times current dose of fat-soluble vitamins by intravenous perfusion
• Conventional dose of fat-Soluble Vitamin
Supplementation of the current dose of fat-soluble vitamins by intravenous perfusion

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xian JiaotongUniversity	Xi'an	Shaanxi

Sponsors (2)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	Xi’an Gaoxin Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. Epu — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamin levels	Change from baseline level of vitamin A, vitamin D, and vitamin E at 4~6 weeks	within 72 hours after birth, 4~6 weeks old
Secondary	Complications	The prevalence of bronchopulmonary dysplasia, patent ductus arteriosus, sepsis, anemia, intracranial hemorrhage, extrauterine growth retardation, etc.	corrected age of 36 weeks
Secondary	Neural development	White matter disease of the preterm infant, was semiquantitatively assessed from MRI at term-equivalent age based on an established scoring method.	corrected age of 40 weeks
Secondary	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	within 72 hours after birth, 4~6 weeks old