NCT03274596

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

Effect of Vitamin E Supplementation on Oxidative Stress and Retinopathy of Prematurity in Preterm Infants <1500 g: A Randomized Clinical Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes · Other Government
• Sex: All
• Age: 3 Days – 3 Days
• Healthy volunteers: Not accepted

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.

Detailed description

Antioxidant defence mechanisms include cellular and extracellular enzymes. Vitamin E is the main fat-soluble vitamin responsible for the protection of cell membranes against peroxidation, thus, it protects polyunsaturated fatty acids from peroxidation which is a step in the pathogenesis of ROP. Previous research on the roles of vitamin E, in the prevention of BPD and ROP was halted because of complications involving sepsis and necrotising enterocolitis. These complications were caused by the compositions of vitamin E oral presentations, which contain polyethylene glycol, propylene glycol, ethanol and, polysorbate 80. These substances, which are used as excipients, may generate adverse effects in premature newborns. These preparations were not used in this project to avoid the development of necrotising enterocolitis, and because these formulations are not commercially available in Mexico. The infants were randomly assigned to one of two groups using a computerized random number generator sequence; this process was handled by the hospital pharmacy staff. The treated group, received vitamin E 12.5 IU orally every 12 hours, from 72 h after birth until 28 days of age, the first blood sample collected from the newborns before the intervention was considered the baseline, and subsequent samples were obtained at 15 and 28 days of age. Control group: received orally sterile water (placebo)

Conditions

• Retinopathy of Prematurity

Interventions

Type	Name	Description
DRUG	Vitamin E
DRUG	Placebo

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-10-01
• Completion: 2015-12-01
• First posted: 2017-09-07
• Last updated: 2017-09-07