Efficacy of water-based vitamin E solution versus placebo in the prevention of retinopathy of prematurity in very low birth weight infants: A randomized clinical trial

Silvia Romero-Maldonado, Araceli Montoya-Estrada, Enrique Reyes-Muñoz, Alberto Martín Guzmán-Grenfell, Yessica Dorin Torres-Ramos, Mario David Sánchez-Mendez, Maricruz Tolentino-Dolores, Manuel Bernardo Salgado-Valladares, Aurora Belmont-Gómez, Nayelli Najéra, Guillermo Ceballos, Jorge Arturo Cardona-Pérez, Juan José Hicks, Javier Mancilla-Ramírez, Silvia Romero-Maldonado, Araceli Montoya-Estrada, Enrique Reyes-Muñoz, Alberto Martín Guzmán-Grenfell, Yessica Dorin Torres-Ramos, Mario David Sánchez-Mendez, Maricruz Tolentino-Dolores, Manuel Bernardo Salgado-Valladares, Aurora Belmont-Gómez, Nayelli Najéra, Guillermo Ceballos, Jorge Arturo Cardona-Pérez, Juan José Hicks, Javier Mancilla-Ramírez

Abstract

Background:: Vitamin E has antioxidant properties, which help in scavenging free radicals, thereby reducing oxidation of lipids and proteins. This study aims to evaluate the efficacy of oral vitamin E supplementation in preventing retinopathy of prematurity (ROP) in very low birth weight (VLBW) infants with respiratory distress syndrome (RDS) and decreasing oxidative stress 15 and 28 days post-intervention.

Methods:: Ninety VLBW infants were randomly assigned to two groups:

  1. 1.

    Treatment (treatment group (T), n = 48) or

  2. 2.

    Placebo (control group (C), n = 42).

Each group received 25 IU of vitamin E (T) or placebo (C).

Results:: The incidence of ROP in groups T and C was 12.5% (n=6) and 31% (n = 13), respectively (RR: 0.40; 95% CI: 0.10–0.96). There were no differences in mortality between groups. As expected, the vitamin E concentration was significantly increased 28 days post-intervention in group T.

Conclusion:: Oral supplementation with vitamin E may effectively prevent ROP development in VLBW infants with RDS. Oxidative damage markers were significantly lower, whereas total antioxidant capacity was increased in group T. However, levels of other antioxidants as vitamin A and C were not measured in two groups.

Trial registration: ClinicalTrials.gov NCT03274596.

Conflict of interest statement

The authors have no conflicts of interest to disclose.

Figures

Figure 1
Figure 1
Flowchart of the participants in the study.
Figure 2
Figure 2
Total antioxidant capacity (TAC) comparison between group T and C. Data are expressed as mean ± standard deviation (SD).
Figure 3
Figure 3
Concentration of Lipohydroperoxide. The generation of lipohydroperoxide (LHP) was 4.2 times higher in group C as compared with group T. Data are expressed as mean ± standard deviation (SD).
Figure 4
Figure 4
Concentration of malondialdehyde. The malondialdehyde (MDA) concentration was significantly higher in group C as compared with that in group T. Data are expressed as mean ± standard deviation (SD).
Figure 5
Figure 5
Protein carbonylation values. Carbonylation was significantly lower in group T than in group C. Data are expressed as mean ± standard deviation (SD).

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