drugset / Trial / NCT03274596

Effect of Vitamin E for Prevention of Retinopathy of Prematurity: A Randomized Clinical Trial.

NCT03274596

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The retinopathy of prematurity (ROP) is a public health problem, the main causes of ROP are prematurity, use of oxygen, malnutrition and oxidative stress. Vitamin E was used beforehand however its use was stopped because of its association with sepsis and enterocolitis caused by the excipient of vitamin E. The purpose of this study is to use vitamin E to prevent ROP, without the previously used excipients.

Timeline

Start
2013-03-01
Primary completion
2015-10-01
Completion
2015-12-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Vitamin E Other / unclassified 12.5 iu Oral