Tolerance of large doses of vitamin A given to mothers and their babies shortly after delivery

Objective: To assess the acute side effects of a 400,000 IU oral dose of vi tamin A given to a newly delivered mother and a 50,000 IU oral dose of vita min A given at the same time to her baby. Design: Randomised double blind placebo controlled clinical trial, with fol low up one to two days after dosing. Setting: Urban maternity centres in Harare, the capital of Zimbabwe. Subjects: 839 newly delivered mothers and babies. Outcome measures: Symptoms and signs possibly attributable to acute vitamin A toxicity in the baby (especially bulging fontanelle) or mother (headache , blurred vision, nausea, vomiting). Results: 788 (94%) of 839 recruits were assessed. Vitamin A and control gro ups were similar in baseline characteristics. The incidence of reported sid e effects was low and comparable to that found previously. Two mothers in e ach group spontaneously reported bulging fontanelles in their babies. One o f these babies (in the placebo group) was reported to have been vomiting. T he rate of incident bulging fontanelles found on examination was 1.5% and 1 .0% in the treatment and control groups respectively (odds ratio 1.48, 95% confidence limits 0.35 and 7.19, p=0.5). Only one baby (in the vitamin A gr oup) of the eleven who were found to have bulging fontanelles on examinatio n had a symptom (vomiting) possibly attributable to raised intracranial pre ssure. Maternal symptoms did not differ between groups. Conclusion: These large doses of vitamin A are well tolerated by newly deli vered mothers and babies. (C) 1999 Elsevier Science Inc.