Moore 2011

Trial name or title	Investigating the effects of prenatal and infancy nutritional supplementation on infant immune development in The Gambia: The Early Nutrition and Immune Development (ENID) Trial.
Methods	A randomised trial to investigate the effects of prenatal and infancy nutritional supplementation on infant immune development.
Participants	Women (aged 18 to 45 years) resident in rural Kiang West Region, the Gambia, with pregnancy confirmed by urine test and ultrasound examination and with gestational age approximately 10‐20 weeks will be recruited. Women currently enrolled in another MRC study or current pregnancy (beyond 20 weeks on ultrasound assessment), with severe anaemia (Hb less than 7 g/dL), reported onset of menopause will be excluded.
Interventions	4 pregnancy interventions, to be given daily from 12 weeks' gestation until delivery: 1. FeFol: Iron‐folate, 60 mg iron 400 µg folate, representing the usual standard of care during pregnancy, as per Gambian Government guidelines (control group). 2. MMN: multiple micronutrients. A combination of 15 micronutrients, specifically designed for use during pregnancy, and as formulated by UNICEF. A single tablet provides the recommended dietary allowance (RDA) for each micronutrient, but we will supplement women in this arm of the trial with 2 daily MMN tablets. 3. PE + FeFol: protein‐energy and iron‐folate. A food‐based supplement developed by Valid International, providing a comparable level of iron and folate to the FeFol only arm, but with the addition of energy, protein and lipids. 4. PE + MMN: protein‐energy and multiple micronutrients. A micronutrient fortified food‐based supplement also developed by Valid International, and providing comparable levels of micronutrients to the MMN arm (including FeFol), in addition to the energy and protein and lipid content. From 6 months of age, infants will further be randomised to receive either a lipid‐based nutritional supplement, with or without additional MMN, or placebo from 6 to 12 months of age.
Outcomes	Primary outcomes: 1. Thymic index at 1, 8, 24 and 52 weeks of age. 2. Antibody response to EPI vaccines (diphtheria, tetanus toxoid, HiB, measles). Secondary outcomes: cellular markers of immunity in a randomly selected subcohort of infants, stratified by treatment group. The secondary outcome measurements will be assessed when the infants are 12, 24 and 52 weeks of age. Subsidiary studies to the main trial will additionally assess the impact of supplementation on infant growth and development to 24 months of age.
Starting date	October 1, 2009.
Contact information	Sophie Moore MRC Keneba MRC Laboratories Fajara, Banjul Gambia PO Box 273 Email: smoore@mrc.gm
Notes	800 mother‐infant pairs.