A randomised 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 6.2% to 8.6%) [corrected]. 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.