A double-blind, randomised, placebo-controlled trial was conducted to
evaluate the safety and toxicity of vitamin A supplementation within t
he Expanded Programme on Immunisation (EPI) in rural Bangladesh. 191 i
nfants received 3 doses of either 50 000 IU of vitamin A or placebo at
about 1.5, 2.5, and 3.5 months and were examined on days 1, 2,3, and
8 after supplementation. 11 infants (11.5%) supplemented with vitamin
A had episodes of bulging of the fontanelle as opposed to 1 (1%) in th
e placebo group. 16 of the 17 events occurred in the vitamin A supplem
ented group. No other side effects were noted. There was a tendency to
wards a cumulative effect of toxicity with increasing doses.