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

Primary Purpose

Vitamin A Deficiency, Vitamin D Deficiency, Vitamin E Deficiency

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
High dose of fat-Soluble Vitamin
Conventional dose of fat-Soluble Vitamin
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin A Deficiency

Eligibility Criteria

undefined - 24 Hours (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • First Affiliated Hospital of Xian JiaotongUniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High dose of fat-soluble vitamins

Conventional dose of fat-soluble vitamins

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 3, 2019
Last Updated
March 13, 2019
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Collaborators
Xi'an Gaoxin Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03876704
Brief Title
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

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 29, 2019 (Actual)
Primary Completion Date
September 30, 2019 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Collaborators
Xi'an Gaoxin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin A Deficiency, Vitamin D Deficiency, Vitamin E Deficiency, Very Low Birth Weight Infants, Bronchopulmonary Dysplasia, Anemia, Sepsis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High dose of fat-soluble vitamins
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional dose of fat-soluble vitamins
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
High dose of fat-Soluble Vitamin
Intervention Description
Supplementation of 5 times current dose of fat-soluble vitamins by intravenous perfusion
Intervention Type
Drug
Intervention Name(s)
Conventional dose of fat-Soluble Vitamin
Intervention Description
Supplementation of the current dose of fat-soluble vitamins by intravenous perfusion
Primary Outcome Measure Information:
Title
Vitamin levels
Description
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 Outcome Measure Information:
Title
Complications
Description
The prevalence of bronchopulmonary dysplasia, patent ductus arteriosus, sepsis, anemia, intracranial hemorrhage, extrauterine growth retardation, etc.
Time Frame
corrected age of 36 weeks
Title
Neural development
Description
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
Title
Gene polymorphism in vitamin deficiency preterm infants
Description
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
Time Frame
within 72 hours after birth, 4~6 weeks old

10. Eligibility

Sex
All
Maximum Age & Unit of Time
24 Hours
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shuang Liu
Phone
008615201524806
Email
liushuangpku@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuang Liu
Organizational Affiliation
First Affiliated Hospital of Xian JiaotongUniversity
Official's Role
Study Director
Facility Information:
Facility Name
First Affiliated Hospital of Xian JiaotongUniversity
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xihui Zhou

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21233795
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.
Results Reference
background
PubMed Identifier
21242240
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.
Results Reference
background
PubMed Identifier
30559825
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.
Results Reference
background
PubMed Identifier
28472980
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.
Results Reference
background
PubMed Identifier
24289974
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.
Results Reference
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Effects of Fat-soluble Vitamins Supplementation on Common Complications and Neural Development in Very Low Birth Weight Infants

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