Acute toxicity of vitamin A given with vaccines in infancy.

A double-blind, randomised, placebo-controlled trial was conducted to evaluate the safety and toxicity of vitamin A supplementation within the Expanded Programme on Immunisation (EPI) in rural Bangladesh. 191 infants 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 the placebo group. 16 of the 17 events occurred in the vitamin A supplemented group. No other side effects were noted. There was a tendency towards a cumulative effect of toxicity with increasing doses.