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 vitamin A given to a newly delivered mother and a 50,000 IU oral dose of vitamin A given at the same time to her baby. Design: Randomised double blind placebo controlled clinical trial, with follow 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 groups were similar in baseline characteristics. The incidence of reported side effects was low and comparable to that found previously. Two mothers in each group spontaneously reported bulging fontanelles in their babies. One of these babies (in the placebo group) was reported to have been vomiting. The 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, 84% confidence limits 0.35 and 7.19, p=0.5). Only one baby (in the vitamin A group) of the eleven who were found to have bulging fontanelles on examination had a symptom (vomiting possibly attributable to raised intracranial pressure. Maternal symptoms did not differ between groups. Conclusion: These large doses of vitamin A are well tolerated by newly delivered mothers and babies.