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

NCT04565314 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-02-26

No results posted yet for this study

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.

Conditions

  • Growth Failure
  • Stunting
  • Malnutrition
  • Protein Malnutrition

Interventions

DIETARY_SUPPLEMENT

Plumpy'Mum

Mothers will consume Plumpy'Mum (one packet daily) from enrollment (child age 0-3 months) for 3 months.

Sponsors & Collaborators

  • Haydom Lutheran Hospital

    collaborator OTHER

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • University of Virginia

    lead OTHER

Principal Investigators

  • Mark D DeBoer, MD, MSc, MCR · University of Virginia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-12
Primary Completion
2022-03-31
Completion
2022-08-01

Countries

  • Tanzania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04565314 on ClinicalTrials.gov