C. Carlier et al., A RANDOMIZED CONTROLLED TRIAL TO TEST EQUIVALENCE BETWEEN RETINYL PALMITATE AND BETA-CAROTENE FOR VITAMIN-A-DEFICIENCY, BMJ. British medical journal, 307(6912), 1993, pp. 1106-1110
Objectives-To determine whether beta carotene is therapeutically equiv
alent to retinyl palmitate in the formulation currently recommended by
the World Health Organisation. Design-Randomised blind equivalence tr
ial. 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 n
ormal 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) ch
ildren taking retinyl palmitate and 50.0% (123/246) of those taking be
ta carotene, who had reverted to normal eye cytology, a difference of
1.2% (95% confidence interval 0.8% to 1.6%). According to an equivalen
ce testing procedure, the two treatments were statistically equivalent
; the null hypothesis of non-equivalence was rejected (one tailed p va
lue=0.03). Conclusions-Beta carotene supplementation seems to be a pro
mising candidate for the alleviation of vitamin A deficiency. It could
be given either as high dose capsule or through increased dietary int
ake. The challenge now is to improve dietary intake of vitamin A in pr
ogrammes that are effective and sustainable at the community level.