ELICIT 2.0: Pilot Study of the Effect of Maternal Protein Supplementation During Lactation on Childhood Growth
ELICIT 2.0: Pilot Study of the Effect of Maternal Protein Supplementation During Lactation on Childhood Growth
Haydom Global Health Research Center in north central Tanzania represents an important rural
 setting for performing high-quality medical research in sub-Saharan Africa. The region around
 Haydom is agricultural (predominantly maize-based), is resource-poor and has a high degree of
 stunting among local infants-with 70% stunting by 18 months in the MAL-ED study and 50% in
 the ELICIT study (for Early Life Interventions for Childhood Growth and Development In
 Tanzania). While the causes of this stunting are multifactorial, a potential contributor is
 early-life nutritional deficiencies, including inadequate dietary protein.

 One likely source of low protein delivery to infants is from low intake among area mothers
 during lactation, with potential effects on breast milk protein content and child weight
 gain. The current study is a pilot study assessing our study team's ability to successfully
 deliver protein-containing food products (a balanced-energy protein supplement) to lactating
 mother is in the area and assessing whether consumption of these food products improves
 childhood growth in the 1st year of life. This is a pilot study because of the potential
 difficulties in distributing these products on a large scale for daily consumption. As such,
 we aim to demonstrate an effective distribution network, a means of assessing adherence, and
 measuring endpoints while gathering knowledge regarding community acceptance. The current
 pilot project will evaluate the effectiveness of distribution and adherence on approximately
 100 mother/child dyads. If effective, a future project could involve a large enough sample to
 be powered to detect reasonable changes in linear growth. .

 So, while the current proposal is not adequately powered to prove a hypothesis, the
 hypothesis underlying the study design is that daily protein supplementation delivered as a
 balanced protein product (Plumpy'mum) to lactating mothers for 3 months during the period
 from 0-6 months post-natal life will result in an increase in infant length-for-age Z-score
 (LAZ) by end of treatment. LAZ will be compared to controls from prior studies in the area.
In severely under-resourced areas of the world, such as the Haydom area in Tanzania (TZ),
 poor nutrition continues contributes to worsened health-related outcomes including growth and
 cognitive development. Haydom Global Health Research Center at Haydom Lutheran Hospital in
 north central Tanzania represents an important rural setting for performing high-quality
 medical research in sub-Saharan Africa. Through ongoing work in the area around Haydom in the
 MAL-ED and ELICIT studies, we have been attempting to improve outcomes for children in an
 area of severe poverty, where there is considerable malnutrition and potential sequelae:

 1. Growth deficits: Poor weight gain and linear growth failure in childhood are often seen as
 surrogates for overall health status; persistently poor growth has implications for future
 work potential and lower human capital. There was a high degree of stunting in the Haydom
 site of Tanzanian in the multi-country observational MAL-ED study, which found that the
 Haydom site had the highest prevalence of stunting among all the MAL-ED sites. This degree of
 stunting is likely multi-factorial, though one contributor is food availability, as rates of
 key factors such as birthweight vary significantly according to food availability. An interim
 analysis of data from our ongoing ELICIT study (for Early Life Interventions for Childhood

 Developmental delays: Perhaps there is no more important outcome (with the exception of
 mortality) than the cognitive, social and emotional development of a population, with clear
 extensions to human capital, economic productivity and quality of life in communities.
 Indeed, many observational and interventional studies (including the current study) follow
 growth as an outcome because of its overall association with cognitive development. In MAL-ED
 assessments, TZ children had fewer words than seen among US children. The reasons for
 potential developmental delays are multifactorial, but again malnutrition may play an
 important role. Studies in other developing areas have demonstrated improved cognitive
 development following delivery of nutrition support.

 Nutritional Causes of Poor Growth

 While the causes of the stunting and developmental delays are multifactorial, a potential
 contributor is early-life nutritional deficiencies, including inadequate dietary protein. One
 likely source of low protein delivery to infants is from low intake among area mothers during
 lactation, with potential effects on breast milk protein content and child weight gain.
 Indeed, the first six months of life represents a critical phase of nutrition for the
 developing infant, in which all (or nearly all) nutrition is delivered through the mother's
 breast milk. However, it is not known whether protein supplementation during lactation in
 this setting would improve childhood growth and reduce stunting-or whether any improvements
 in growth would continue beyond the period of maternal supplementation.

 Assessing the potential effect of mothers receiving protein supplementation-using a balanced
 energy protein supplement-on childhood growth and development would require an approach that
 incorporates an effective distribution network, a means of assessing adherence, and a
 thorough knowledge of community acceptance, as well as accurate measures of endpoints on a
 large enough sample to be powered to detect reasonable changes in linear growth. In order to
 assess the feasibility of this type of approach on a smaller scale (which could be later be
 expanded), the current pilot project will evaluate the effectiveness of distribution and
 adherence on approximately 100 mother/child dyads. If this experimental approach is feasible
 and shows promise, it is our hope to follow it with a larger study that offers more
 definitive evidence of efficacy.
Inclusion Criteria:

 -  Maternal age >/= 18 years

 -  Current pregnancy or infant </= 3 months

 Exclusion Criteria:

 -  Maternal inability to adhere to protocol

 -  Multiple gestation

 -  Significant birth defect

 -  Maternal allergy to peanut, milk or soy

 -  Lack of breast feeding at enrollment (and lack of intention to continue breast feeding
 at time of enrollment