TY - JOUR
T1 - Tolerance of young infants to a single, large dose of vitamin A
T2 - A randomized community trial in Nepal
AU - West, K. P.
AU - Khatry, S. K.
AU - LeClerq, S. C.
AU - Adhikari, R.
AU - See, L.
AU - Katz, J.
AU - Shrestha, S. R.
AU - Pradhan, E. K.
AU - Pokhrel, R. P.
AU - Sommer, A.
PY - 1992
Y1 - 1992
N2 - A randomized, double-masked trial was carried out in rural Nepal to investigate the incidence and severity of acute side-effects among neonates (< 1 month of age) and infants aged 1-6 months who received a large, oral dose of vitamin A (15000 retinol equivalents (RE) (50000 IU) and 30000 RE (100000 IU), respectively) or placebo (75 RE (250 IU) and 150 RE (500 IU), respectively) in oil. Infants (vitamin A group, n = 1461; controls, n = 1379) were assessed for vomiting, loose stools, fever, and irritability during the 24 hours before and after dosing. Fontanelles were palpated 24 hours after dosing. Neonates exhibited no excess risk of adverse side-effects after receiving 15000 RE. Compared with controls the older infants who ingested 30000 RE had a 1.6% excess rate of vomiting (95% confidence interval (CI): 0.2-3.0%) and a 0.5% excess rate (95% CI: -0.1 to 1.1%) in the occurrence of bulging fontanelles. There were no other significant differences in the older infants. The controlled, periodic distribution of a single 15000 RE dose of vitamin A therefore confers no apparent acute risk to young infants; a 30000 RE dose is associated with a minimum risk of transient, acute side-effects.
AB - A randomized, double-masked trial was carried out in rural Nepal to investigate the incidence and severity of acute side-effects among neonates (< 1 month of age) and infants aged 1-6 months who received a large, oral dose of vitamin A (15000 retinol equivalents (RE) (50000 IU) and 30000 RE (100000 IU), respectively) or placebo (75 RE (250 IU) and 150 RE (500 IU), respectively) in oil. Infants (vitamin A group, n = 1461; controls, n = 1379) were assessed for vomiting, loose stools, fever, and irritability during the 24 hours before and after dosing. Fontanelles were palpated 24 hours after dosing. Neonates exhibited no excess risk of adverse side-effects after receiving 15000 RE. Compared with controls the older infants who ingested 30000 RE had a 1.6% excess rate of vomiting (95% confidence interval (CI): 0.2-3.0%) and a 0.5% excess rate (95% CI: -0.1 to 1.1%) in the occurrence of bulging fontanelles. There were no other significant differences in the older infants. The controlled, periodic distribution of a single 15000 RE dose of vitamin A therefore confers no apparent acute risk to young infants; a 30000 RE dose is associated with a minimum risk of transient, acute side-effects.
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M3 - Article
C2 - 1486669
AN - SCOPUS:0027082233
SN - 0043-9686
VL - 70
SP - 733
EP - 739
JO - Bulletin of the World Health Organization
JF - Bulletin of the World Health Organization
IS - 6
ER -