Vitamin a megadoses during early infancy on serum retinol concentration and acute side effects and residual effects on 6 month follow-up

We evaluated the safety and efficacy of 3 oral doses of 50000 IU vitamin A at monthly intervals in predominantly breastfed infants from poor urban Bangladesh aged 6 to 17 weeks along with DPT and oral polio vaccines in a randomised double-masked controlled trial. Ninety-seven infants received vitamin A and 103 received placebo. Initial fasting serum retinol concentrations were very low in most infants (52% <10 µg/dl and 74% <15 µg/dl) which improved in both groups but was still less than 15 µg/dl in 30% of those who received vitamin A. Nine infants in the vitamin A group and 2 in the placebo group had bulged fontanelle after the second and/or third dose (RR=4.78 95% CI 1.06-21.54 P<0.025) which resolved in 48 hours. In conclusion young infants from a deprived urban community in Bangladesh were deficient in vitamin A; a large proportion remained deficient even after three large doses of vitamin A. In spite of deficiency bulged fontanelle an apparent toxic manifestation occurred in 9.3% with this dosage schedule of vitamin A. Alternative and/or complementary approaches e.g. maternal supplementation are needed to prevent vitamin A deficiency in under 6 month infants in developing countries. (authors)