A randomised trial to investigate the effects of pre-natal and in infancy nutritional supplementation on infant immune development in rural Gambia (The ENID Trial: Early Nutrition and Immune Development). ISRCTN49285450
Recent observational research from our group and others indicates that immune development may be programmed by nutritional exposures early in life. Rather than pursuing further exploratory studies, that anyway may not reveal definitive links between nutrient deficits and immunodeficiency on which to build a specific interventional strategy, the recent development of affordable lipid based nutrient supplements (LNS) allows us to move straight to a proof of principle intervention trial employing comprehensive multiple micronutrient (MMN) and protein energy (PE) supplements. This trial seeks to establish: (a) which combination of PE and MMN supplements would be most effective; and (b) the most critical periods for intervention in pregnancy and infancy. The primary outcome measures of this study will be thymic development during infancy, and antibody response to vaccination. To validate the significance of TI, we will additionally measure cellular markers of immunity in a randomly selected sub-cohort (stratified by treatment group). The primary hypothesis of this trial is that early-life immunocompetence can be enhanced by a life-course approach to achieve nutritional repletion in late gestation and infancy.
The ENID Trial timeline and schedule for visits, measurements and sample collections is detailed here:
[Note to Pierre – these links have not worked since you put them up. Can you try to sort it?]
The framework for the ENID Trial is supporting a number of adjunct studies:
- The effects of nutritional supplementation in pregnancy on the bone health, body composition and nutrient intake of mother and child
- The effect of prenatal and early childhood nutritional supplementation on infant and early childhood body composition, growth and development
- Effects of micronutrient supplementation during pregnancy on placental function in a Gambian population
- Breast milk bioactives and the defense of gut and growth.
[NB The links above can use the material currently on the website, this doesn’t need to be updated]