Status:
UNKNOWN
Effects of Fat-soluble Vitamins Supplementation on Common Complications and Neural Development in Very Low Birth Weight Infants
Lead Sponsor:
First Affiliated Hospital Xi'an Jiaotong University
Collaborating Sponsors:
Xi'an Gaoxin Hospital
Conditions:
Vitamin A Deficiency
Vitamin D Deficiency
Eligibility:
All Genders
Up to 24 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03876704
Start Date
January 29 2019
End Date
December 31 2020
Last Update
March 15 2019
Active Locations (1)
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1
First Affiliated Hospital of Xian JiaotongUniversity
Xi'an, Shaanxi, China, 710061