A RANDOMIZED CONTROLLED TRIAL TO TEST EQUIVALENCE BETWEEN RETINYL PALMITATE AND BETA-CAROTENE FOR VITAMIN-A-DEFICIENCY

Objectives-To determine whether beta carotene is therapeutically equivalent to retinyl palmitate in the formulation currently recommended by the World Health Organisation. Design-Randomised blind equivalence trial. Setting-Rural area in Senegal. Subjects-Children aged 2-15 years suffering from vitamin A deficiency as defined by abnormal results on eye cytology were randomly allocated treatment with retinyl palmitate (n=256) and beta carotene (n=254). Main outcome measure-Reversion to normal results on eye cytology as defined by the reappearance of goblet cells and normalisation of the epithelial cells. Results-Seven weeks after the supplement was given the percentages were 51.2% (124/242) children taking retinyl palmitate and 50.0% (123/246) of those taking beta carotene, who had reverted to normal eye cytology, a difference of 1.2% (95% confidence interval 0.8% to 1.6%). According to an equivalence testing procedure, the two treatments were statistically equivalent; the null hypothesis of non-equivalence was rejected (one tailed p value=0.03). Conclusions-Beta carotene supplementation seems to be a promising candidate for the alleviation of vitamin A deficiency. It could be given either as high dose capsule or through increased dietary intake. The challenge now is to improve dietary intake of vitamin A in programmes that are effective and sustainable at the community level.