Skip to main content
OpenTrials
Completed

NCT Number: NCT03385252

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

6 month–9 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Malawi College of Medicine, Mangochi Campus

Mangochi, Malawi

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eggs

Other

Eggs provided as complementary food for the infant

Visits

Behavioral

Twice weekly household visits by study staff

Primary outcomes

  1. 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

  2. Stunting

    Time frame: 6 months after the start of the intervention

    Prevalence of length-for-age z-score <-2

Secondary outcomes

  1. Weight-for-age z-score and prevalence of underweight (WAZ<-2)

    Time frame: 6 months after the start of the intervention

  2. Weight-for-length z-score and prevalence of wasting (WLZ<-2)

    Time frame: 6 months after the start of the intervention

  3. Plasma choline concentration

    Time frame: 6 months after the start of the intervention

    Venous blood collection

  4. Plasma amino acid concentrations

    Time frame: 6 months after the start of the intervention

    Venous blood collection

  5. 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

Other outcomes

  1. 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

  2. Microbiome: microbial diversity and abundance

    Time frame: Each month for 6 months

    Stool sample collection

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

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

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 28, 2017
Registry last updated
Feb 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.