Tolerance of preschoolers to two dosage strengths of vitamin A preparation

Abstract

The tolerance to two alternative large-dosage strengths of vitamin A preparation was determined in a double-blind study involving 2471 children in two municipalities in the Philippines. Each child, aged 1–6 y, not suffering from active xerophthalmia or from nausea and/or vomiting, headache, diarrhea, and fever, was randomly given 1 mL of a syrupy suspension later identified to contain 0, 60, or 30 mg vitamin A. Clinical evaluation of subjects was done by physicians 24 h and 1 wk after dosing. Nausea and/or vomiting and headache were twice as common among children given 60 mg than those given 30 mg. Severe vomiting (1.2%) was confined to those given 60 mg. Almost all experienced their symptoms within 24 h after dosing; symptoms lasted for no more than 12–24 h. The incidence of diarrhea and fever for vitamin A recipients was not significantly different from that of those receiving placebo.