Clinical trial NCT04565314: ELICIT 2.0: Pilot Study of the Effect of Maternal Protein Supplementation During Lactation on Childhood Growth
Official title: ELICIT 2.0: Pilot Study of the Effect of Maternal Protein Supplementation During Lactation on Childhood Growth
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Growth Failure
Stunting
Malnutrition
Protein Malnutrition
Keywords: protein
breast feeding
eggs
Ready-to-eat food
infant
growth
Tanzania
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Haydom Lutheran Hospital
name: Bill and Melinda Gates Foundation
First posted: 2020-09-25
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participating mothers nursing children age 0-3 months at enrollment will receive 3 months of treatment with one packet of Plumpy'Mum.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Family perception of Plumpy'Mum
timeFrame: at 3 months after enrollment
Secondary outcomes:
measure: Child weight-for-age Z-score (WAZ) after 3 months of Plumpy'Mum use
timeFrame: 3 months
measure: Child head circumference-for-age Z-score (HCZ) after 3 months of Plumpy'Mum use
timeFrame: 3 months
measure: Child mid-upper arm circumference-for-age Z-score (MUAC-Z) after 3 months of Plumpy'Mum use
timeFrame: 3 months
measure: Child length-for-age Z-score (LAZ) after 3 months of Plumpy'Mum use
timeFrame: 3 months
measure: Adverse events
timeFrame: 3 months
measure: Maternal weight at 3 months
timeFrame: 3 months
measure: Maternal mid-upper arm circumference-for-age Z-score (MUAC) at 3 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Mbulu
country: Tanzania
facility: Haydom Lutheran Hospital
state: Manyara
Study officials:
affiliation: University of Virginia
name: Mark D DeBoer, MD, MSc, MCR
role: PRINCIPAL_INVESTIGATOR
References: