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

NCT03876704 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-03-15

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

High dose of fat-Soluble Vitamin

Supplementation of 5 times current dose of fat-soluble vitamins by intravenous perfusion

DRUG

Conventional dose of fat-Soluble Vitamin

Supplementation of the current dose of fat-soluble vitamins by intravenous perfusion

Sponsors & Collaborators

  • First Affiliated Hospital Xi'an Jiaotong University

    lead OTHER

  • Xi'an Gaoxin Hospital

    collaborator OTHER

Principal Investigators

  • Shuang Liu · First Affiliated Hospital of Xian JiaotongUniversity

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
24 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-29
Primary Completion
2019-09-30
Completion
2020-12-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03876704 on ClinicalTrials.gov