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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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ClinicalTrials.gov Identifier: NCT03876704
Recruitment Status : Recruiting
First Posted : March 15, 2019
Last Update Posted : March 15, 2019
Sponsor:
Collaborator:
Xi’an Gaoxin Hospital
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

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

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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


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




Primary Outcome Measures :
  1. 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 :
  1. Complications [ Time Frame: corrected age of 36 weeks ]
    The prevalence of bronchopulmonary dysplasia, patent ductus arteriosus, sepsis, anemia, intracranial hemorrhage, extrauterine growth retardation, etc.

  2. 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.

  3. 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



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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

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

Publications of Results:
Other Publications:
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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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Eye Diseases
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
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs