The Mazira Project: An Evaluation of Eggs During Complementary Feeding in Rural Malawi

February 20, 2020 updated by: University of California, Davis
The Mazira Project is a study of the effect of egg consumption on growth, development and gut health of infants in Malawi. The study randomly assigns infants to receive one egg per day over six months or to receive an equivalent value of food at the end of six months. Growth, achievement of developmental milestones, gut microbiome composition and other measures of nutritional status are compared between the two groups to determine whether regular egg consumption benefits Malawian infants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of the Mazira Project is to determine whether daily consumption of an egg improves the growth and development of infants in rural Malawi. In Malawi, 37% of children under five years old are stunted, or shorter than expected for their age (1). Most stunting occurs when children are less than 2 years old. Stunting is a sign of long-term undernutrition and is associated with delayed cognitive development. Eggs provide protein, fatty acids, vitamin B12, choline and other nutrients that may support healthy growth and cognitive development. In a previous trial in Ecuador, infants who were provided eggs for daily consumption showed improved growth and lower rates of stunting than infants who were not provided eggs (2).

Investigators are assessing whether children who consume eggs regularly over six months starting when they are 6 to 9 months old have higher height-for-age scores and lower rates of stunting than children who do not consume eggs regularly. Investigators are also assessing whether egg consumption improves Malawian infants' cognitive development. Because gut health is important for good nutrition, they are testing whether eggs have positive effects on measures of gut health and the gut microbiome. Finally, they are exploring the various metabolic pathways by which the nutrients available in eggs may influence infant growth and development.

Participants are individually, randomly assigned to the egg intervention group or the control group. The mothers of infants who are randomly assigned to the egg intervention group receive 14 eggs each week and are asked to feed the infant one egg each day. Extra eggs are provided because sharing of food is common in Malawian households. The mothers of infants who are randomly assigned to the control group receive a package of foods at the end of the study that is equal in value to the eggs. Each mother/infant pair participates in the study for six months.

When infants are enrolled, a baseline assessment is completed. This assessment includes a blood draw plus testing for anemia and malaria, anthropometric measurements, developmental assessments, 24-hour dietary recall interview, infant health history questionnaire. Mothers' heights and weights are also measured, and each mother is asked about socio-economic and demographic indicators and food security in her household. The anthropometric, dietary and development assessments are repeated after 3 months. At the end of the six month study period, anthropometric, dietary and development assessments are repeated, along with another blood draw.

Additional data collected during the course of the study include: repeat 24-hour dietary recalls and monthly stool sample collection among a subsample of 200 children; twice-weekly observations of the index infant's egg consumption in the egg group or short questionnaire about the index infant's most recent meal in the control group; weekly morbidity history and animal source food consumption questionnaire among all infants; and focus groups and key informant interviews about production, availability and consumption of eggs among communities in the study area.

Study Type

Interventional

Enrollment (Actual)

662

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malawi
      • Mangochi, Malawi
        • University of Malawi College of Medicine, Mangochi Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 9 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Living in catchment area of Lungwena health center, Mangochi District, Malawi during the study enrollment period
  • Singleton birth

Exclusion Criteria:

  • Egg allergy
  • History of anaphylaxis or any serious allergic reaction requiring emergency medical care
  • Congenital or chronic condition impacting growth and development or ability to eat eggs
  • Severe anemia (hemoglobin < 5 g/dL)
  • Mid-upper arm circumference < 12.5 cm or presence of bipedal edema
  • Acute illness or injury warranting hospital referral

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Egg Group
Egg Intervention: Provision of eggs to caregivers of enrolled infants, with instructions to prepare and feed one egg to the infant each day for 6 months time. Households will be visited twice weekly to provide eggs and monitor intake.
Other: Eggs
Eggs provided as complementary food for the infant
Behavioral: Visits
Twice weekly household visits by study staff
Active Comparator: Control Group
Control Group: Caregivers will receive a food basket at the end of the study. Throughout the trial, households will be visited twice weekly and asked about food intake.
Behavioral: Visits
Twice weekly household visits by study staff

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length-for-age z-score
Time Frame: 6 months after the start of the intervention
Child's recumbent length, standardized using the World Health Organization growth standards
6 months after the start of the intervention
Stunting
Time Frame: 6 months after the start of the intervention
Prevalence of length-for-age z-score <-2
6 months after the start of the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight-for-age z-score and prevalence of underweight (WAZ<-2)
Time Frame: 6 months after the start of the intervention
6 months after the start of the intervention
Weight-for-length z-score and prevalence of wasting (WLZ<-2)
Time Frame: 6 months after the start of the intervention
6 months after the start of the intervention
Plasma choline concentration
Time Frame: 6 months after the start of the intervention
Venous blood collection
6 months after the start of the intervention
Plasma amino acid concentrations
Time Frame: 6 months after the start of the intervention
Venous blood collection
6 months after the start of the intervention
Cognitive development
Time Frame: 6 months after the start of the intervention
Measured using the Malawi Development Assessment Tool (MDAT), Infant eye-tracking measures of declarative memory, and delayed imitation tasks
6 months after the start of the intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma concentrations of micronutrient biomarkers (iron, zinc, vitamin A, B12) and lipids
Time Frame: 6 months after the start of the intervention
Venous blood collection
6 months after the start of the intervention
Microbiome: microbial diversity and abundance
Time Frame: Each month for 6 months
Stool sample collection
Each month for 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

Washington University School of Medicine
Kamuzu University of Health Sciences
University of Maryland, College Park

Investigators

  • Principal Investigator: Christine P Stewart, PhD, University of California, Davis
  • Principal Investigator: Chessa Lutter, PhD, University of Maryland, College Park
  • Principal Investigator: Kenneth M Maleta, PhD, Kamuzu University of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2018

Primary Completion (Actual)

January 22, 2019

Study Completion (Actual)

January 22, 2019

Study Registration Dates

First Submitted

December 20, 2017

First Submitted That Met QC Criteria

December 20, 2017

First Posted (Actual)

December 28, 2017

Study Record Updates

Last Update Posted (Actual)

February 24, 2020

Last Update Submitted That Met QC Criteria

February 20, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1125193

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified data will be posted in a publicly accessible repository on the Open Science Framework website. Publicly shared data will include all the individual participant data that underlie the results in each publication.

IPD Sharing Time Frame

The study protocol and statistical analysis plan for the primary outcome analysis will be posted before data analysis begins. Data and analytic code will be posted within 6 months after publication of the primary outcome results.

IPD Sharing Access Criteria

Published data will be made publicly accessible. Unpublished data may be requested by contacting the study Principal Investigator.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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