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

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ClinicalTrials.gov Identifier: NCT03876704

Recruitment Status : Recruiting

First Posted : March 15, 2019

Last Update Posted : March 15, 2019

See Contacts and Locations

Sponsor:

Collaborator:

Xi’an Gaoxin Hospital

Information provided by (Responsible Party):

First Affiliated Hospital Xi'an Jiaotong University

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
Vitamin A Deficiency Vitamin D Deficiency Vitamin E Deficiency Very Low Birth Weight Infants Bronchopulmonary Dysplasia Anemia Sepsis	Drug: High dose of fat-Soluble Vitamin Drug: Conventional dose of fat-Soluble Vitamin	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	120 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Effects of Fat-soluble Vitamins Supplementation in Early Life on Common Complications and Neural Development in Very Low Birth Weight Infants
Actual Study Start Date :	January 29, 2019
Estimated Primary Completion Date :	September 30, 2019
Estimated Study Completion Date :	December 31, 2020

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Ataxia with vitamin E deficiency

MedlinePlus related topics: Birth Weight Vitamin A

Genetic and Rare Diseases Information Center resources: Bronchopulmonary Dysplasia Keratomalacia

U.S. FDA Resources

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 [ Time Frame: 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 [ Time Frame: corrected age of 36 weeks ]
The prevalence of bronchopulmonary dysplasia, patent ductus arteriosus, sepsis, anemia, intracranial hemorrhage, extrauterine growth retardation, etc.
Neural development [ Time Frame: 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 [ Time Frame: 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

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Ages Eligible for Study:	up to 24 Hours (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03876704

Contacts

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Contact: Shuang Liu	008615201524806	liushuangpku@126.com

Locations

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China, Shaanxi
First Affiliated Hospital of Xian JiaotongUniversity	Recruiting
Xi'an, Shaanxi, China, 710061
Contact: Xihui Zhou

Sponsors and Collaborators

First Affiliated Hospital Xi'an Jiaotong University

Xi’an Gaoxin Hospital

Investigators

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Study Director:	Shuang Liu	First Affiliated Hospital of Xian JiaotongUniversity

More Information

Publications of Results:

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.

Other Publications:

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.

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.

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.

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Responsible Party:	First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier:	NCT03876704 History of Changes
Other Study ID Numbers:	2018MSZC-04
First Posted:	March 15, 2019 Key Record Dates
Last Update Posted:	March 15, 2019
Last Verified:	February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

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Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Additional relevant MeSH terms:

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Body Weight Birth Weight Vitamin D Deficiency Bronchopulmonary Dysplasia Vitamin A Deficiency Night Blindness Vitamin E Deficiency Signs and Symptoms Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Ventilator-Induced Lung Injury	Lung Injury Lung Diseases Respiratory Tract Diseases Infant, Premature, Diseases Infant, Newborn, Diseases Vision Disorders Eye Diseases Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs

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