Oral vitamin A supplementation in very low birth weight neonates: a randomized controlled trial

This randomized double-blind placebo-controlled trial evaluated the effects of early postnatal oral vitamin A supplementation (VAS) in 196 inborn very-low birth weight (VLBW) infants requiring respiratory support at 24h of age. Eligible infants were randomized to receive aqueous syrup of vitamin A (10,000IU of retinol/dose; n=98) or placebo (n=98) on alternate days for 28days. Primary outcome variable was composite incidence of all-cause mortality and/or oxygen requirement for 28days. Secondary outcome variables were safety/tolerability of VAS, serum retinol concentration at recruitment and day 28, duration of oxygen requirement and respiratory support and incidences of complications. On intention-to-treat analysis, composite incidence of all-cause mortality and oxygen requirement for 28days was significantly lower in vitamin A group (relative risk (95% confidence interval), 0.440 (0.229-0.844); p<0.05, number needed to benefit, 7). Requirement and duration of oxygen supplementation and non-invasive respiratory support, incidences of late-onset sepsis, patent ductus arteriosus, and duration of hospital stay were also significantly lower in vitamin A group. Serum retinol concentration improved significantly after VAS. No major adverse effect was observed.Conclusions: Early postnatal oral VAS was associated with better composite outcome of all-cause mortality and oxygen requirement without any major adverse effects.Clinical Trial Registration: Clinical Trials Registry of India (CTRI/2017/03/008131).