ELICIT 2.0: Pilot Study of the Effect of Maternal Protein Supplementation During Lactation on Childhood Growth

Primary Investigator

  • Mark D. DeBoer

Study Period

November 2020 - June 2022

Study Description

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 (eggs or 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 200 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 either 2 eggs or a balanced protein product (Plumpy'mum) to lactating mothers from 0-6 months post-natal life will result in an increase in infant length-for-age Z-score (LAZ) by age 12 months. LAZ will be compared between groups and to controls from prior studies in the area.

Study Arms

  • Experimental: Eggs Mother/child dyads will be enrolled at child age 0-14 days and mothers will immediately begin consuming 2 eggs daily. Eggs will be provided by the study team to the mother, who will prepare them as she desires.
  • Experimental: Plumpy'Mum: Mother/child dyads will be enrolled at child age 0-14 days and mothers will immediately begin consuming a packet of Plumpy'Mum (or similar protein food product) daily.

Primary Outcomes

  • Child length-for-age Z-score (LAZ) at 12 months
  • Child weight-for-age Z-score (WAZ) at 12 months
  • Child head circumference-for-age Z-score (HCZ) at 12 months

Study Interventions

  • Standard Lipid-Based Nutrient Supplements (LNS)
  • Plant-source protein
  • Animal-source protein

Research Gaps

  • Acceptability

    Which food products do recipients enjoy eating and have the fewest side effects?

  • Effectiveness

    How well do different food compositions and interventions prevent or treat undernutrition, when implemented "on the ground"?

Study Population

200