Randomised trial to assess benefits and safety of vitamin A supplementation linked to immunisation in early infancy.
Background The benefits and safety of vitamin A supplementation linked to immunisation in infancy need to be assessed before it can be widely recommended.
We assessed the safety and benefits of maternal postpartum and infant vitamin A supplementation administered with each of the three diphtheria-tetanus-pertussis (DPT) and poliomyelitis immunisations and with a fourth dose with measles immunisation.
Methods From January, 1995, we enrolled 9424 mother-infant pairs from Ghana, India, and Peru in this randomised, double-blind, placebo-controlled trial. 4716 mothers of infants in the vitamin A group received 200 000 IU vitamin A, and their infants were given 25 000 IU vitamin A with each of the first three doses of DPT/poliomyelitis immunisation at 6,10, and 14 weeks.
In the control group, 4708 mothers and their infants received placebo at the same times.
At 9 months, with measles immunisation, infants in the vitamin A group were given a further dose of 25 000 IU and those in the control group received 100 000 IU vitamin A. Infants were followed up to age 12 months.
The primary outcome measures were vitamin A status, signs of acute toxic effects, anthropometric indicators, and severe morbidity.
Analysis was by intention to treat.
Findings 3933 (93%) of the eligible 4212 infants on vitamin A and 3938 (93%) of the eligible 4227 controls received all four study doses. (...)
Mots-clés Pascal : Immunisation active, Nourrisson, Homme, Essai thérapeutique contrôlé, Rétinol, Supplémentation, Randomisation, Etude double insu, Evaluation, Efficacité, Sécurité, Pays en développement, Immunologie, Prévention, Vitamine
Mots-clés Pascal anglais : Active immunization, Infant, Human, Controlled therapeutic trial, Retinol, Supplementation, Randomization, Double blind study, Evaluation, Efficiency, Safety, Developing countries, Immunology, Prevention, Vitamin
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 98-0489765
Code Inist : 002B02N. Création : 19/02/1999.