Randomized placebo-controlled clinical trial of the effect of a single high dose or daily low doses of vitamin A on the morbidity of hospitalized, malnourished children

The effect of high-dose vitamin A supplementation on recovery from morbidit y and on recovery from nosocomial morbidity of hospitalized children has be en poorly studied and results are conflicting. The effect of daily, low dos es has never been assessed. We investigated the effect of a single high dos e and daily, low doses of vitamin A on diarrhea, acute lower respiratory tr act infections (ALRIs), and all-cause fevers in 900 hospitalized preschool- age children in the Democratic Republic of Congo in a randomized, double-bl ind, placebo-controlled clinical trial. The high-dose treatment group recei ved 200 000 IU vitamin A (100 000 IU if aged <12 mo) orally on the day of a dmission, the low-dose treatment group received 5000 IU vitamin Aid until d ischarge. Data on all-cause morbidity were collected daily. Mortality rates were not significantly different among the 3 groups. High-dose vitamin A s upplementation had no significant effect on the duration of moderate or sev ere diarrhea nor on the duration and incidence of ALRIs and all-cause fever s. Children in the high-dose group with no edema had an increased risk of s evere nosocomial diarrhea (relative risk: 2.42; 95% CI: 1.15, 5.11). Low-do se vitamin A supplementation significantly reduced the incidence of severe diarrhea in severely malnourished children (relative risk: 0.21; 95% CI: 0. 07, 0.62) but showed no significant effect on the duration of moderate or s evere diarrhea or on the duration and incidence of ALRIs and all-cause feve rs. Supplementation with high doses of vitamin A did not reduce morbidity i n this population of malnourished and subclinically vitamin A-deficient chi ldren: daily, low doses appeared more beneficial for severely malnourished children.