A randomized trial to investigate the effects of pre-natal and infant nutritional supplementation on infant immune development in rural Gambia: the ENID trial: Early Nutrition and Immune Development

ENID was a randomized factorial trial in pregnant women in rural West Kiang, The Gambia, enrolled before 20 weeks gestation, and followed with their infants through the first year of life. Eligibility included women aged 18 to 45 years, with recruitment through MRC Keneba and the West Kiang Demographic Surveillance System; the trial aimed for complete data on 800 mother-infant pairs and was allowed to recruit up to 1000 pregnancies to account for attrition.

This randomized factorial trial tested several oral nutritional regimens. During pregnancy, women received either a weekly multiple micronutrient tablet from booking to delivery, a weekly protein-energy lipid-based supplement plus iron and folate from booking to delivery, or a weekly protein-energy lipid-based supplement fortified with multiple micronutrients from booking to delivery. From 6 to 12 months of age, infants received 20 g daily of an oral lipid-based nutritional supplement mixed with weaning food, either unfortified or fortified with multiple micronutrients.

No efficacy results are reported in this paper; it describes the ENID trial design and intended outcomes. The study was designed to test whether prenatal and infant nutritional supplementation could improve infant immune development, especially thymic development measured by thymic index at weeks 1, 8, 24, and 52 and antibody responses to vaccination. If benefit is shown, the trial is intended to identify the most effective supplement formulation and the most important timing of exposure during pregnancy or infancy.

This source is a trial design paper rather than a results report, so no treatment effect can be assessed. Per-arm sample sizes, allocation ratios, and arm-level demographic or outcome results are not provided. Generalizability is limited by the rural Gambian setting and by the fact that the evidence here is only protocol-level information.