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Effects of Early Vitamin A Supplementation on the Risk for Retinopathy of Prematurity in Extremely Preterm Infants

NCT03154723 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 262

Last updated 2018-09-05

No results posted yet for this study

Summary

Retinopathy of prematurity (ROP) is a common retinal neovascular disorder and major cause of vision impairment or blindness, despite current treatment of late stage ROP. Because the visual disorders after treatment are often poor, preventive therapy for ROP is still lacking. Although ROP is a multifactorial disease, the altered regulation of vascular endothelial growth factor (VEGF) and insulin-like growth factor (IGF-1) have been implicated in the pathogenesis of ROP. Vitamin A is one of the most important micronutrients affecting the health of children. Supplementing newborn infants with vitamin A within the first 2 days of life reduced infant mortality by almost 25%, with the greatest benefit to those of low birth weight. Vitamin A has been used in this population prophylactically for chronic lung disease with the large doses and no reported significant adverse effect exists. It is suggested that vitamin A-retinoids and their active metabolite, retinoic acid (RA) have highly potent antiangiogenic activity by inhibiting VEGF expression. Vitamin A (retinol) is converted into retinoic acid in cells. However, the significance of Vitamin A administration has not been investigated to our knowledge in an experimental ROP infant. The aim of this study was to perform prospective, multicenter, randomized design to demonstrate the preventive effect of Vitamin A on ROP.

Conditions

  • Retinopathy of Prematurity

Interventions

DRUG

Vitamin A

Vitamin A daily dose 1500IU/day will be added to infant's enteral feeds in drop form as soon as minimal feeding is introduced. The vitamin A supplementation was last for 28 days.

Sponsors & Collaborators

  • Zhengzhou University

    collaborator OTHER

  • Huiqing Sun

    lead OTHER

Principal Investigators

  • Ligong Hou, MD · Chidren's Hospital of Zhengzhou

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Hour
Max Age
45 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-01
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • China

Study Locations

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Read the full study record

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View NCT03154723 on ClinicalTrials.gov