title: Bulging fontanelle after supplementation with 25,000 IU of vitamin A in infancy using immunization contacts.
abstract: To evaluate the safety of vitamin A supplementation in early infancy using DPT/OPV immunization contracts, a double-blind, randomized, placebo-controlled trial was conducted in Bangladesh. One hundred and sixty-seven infants received three doses of either 25,000 IU of vitamin A or a placebo at about 6.5, 11.8 and 17.0 weeks of age. Trained physicians examined each of the infants on days 1, 2, 3 and 8 after supplementation. Nine infants (10.5%) supplemented with vitamin A had episodes of bulging of the fontanelle compared with two infants (2.5%) in the placebo group (p < 0.05). Twelve of the 14 episodes occurred in infants supplemented with vitamin A. Of these 12 episodes, none occurred with the first dose, 3 occurred with the second and 9 with the third dose. The higher incidence of bulging of the fontanelle in the vitamin A group relative to the placebo group and its temporal association with the vitamin A doses are suggestive of a causal association. The finding that increased numbers of vitamin A doses were associated with a higher probability of bulging of the fontanelle suggests a cumulative effect.
mesh_terms: D001459:Bangladesh; D003906:Developing Countries; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006986:Hypervitaminosis A / Q000209:etiology*; D017589:Immunization Programs; D007223:Infant; D008297:Male; D011055:Poliovirus Vaccine, Oral / Q000008:administration & dosage; D011559:Pseudotumor Cerebri / Q000139:chemically induced* / Q000175:diagnosis; D014505:Urban Population; D014801:Vitamin A / Q000008:administration & dosage / Q000009:adverse effects*
chemical_list: D015721:Diphtheria-Tetanus-Pertussis Vaccine; D011055:Poliovirus Vaccine, Oral; D014801:Vitamin A