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

Infant Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03385252
• Other study ID #: 1125193
• Status: Completed
• Phase: N/A
• Start date: January 22, 2018
• Est. completion date: January 22, 2019

Study information

• Verified date: February 2020
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 662
• Est. completion date: January 22, 2019
• Est. primary completion date: January 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 9 Months

Eligibility

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

Related Conditions & MeSH terms

• Infant Malnutrition
• Infant Nutrition Disorders
• Malnutrition

Intervention

Other:
• Eggs
Eggs provided as complementary food for the infant

Behavioral:
• Visits
Twice weekly household visits by study staff

Locations

Country	Name	City	State
Malawi	University of Malawi College of Medicine, Mangochi Campus	Mangochi

Sponsors (4)

Lead Sponsor	Collaborator
University of California, Davis	University of Malawi College of Medicine, University of Maryland, College Park, Washington University School of Medicine

Country where clinical trial is conducted

Malawi, 

References & Publications (3)

Iannotti LL, Lutter CK, Stewart CP, Gallegos Riofrío CA, Malo C, Reinhart G, Palacios A, Karp C, Chapnick M, Cox K, Waters WF. Eggs in Early Complementary Feeding and Child Growth: A Randomized Controlled Trial. Pediatrics. 2017 Jul;140(1). pii: e20163459. doi: 10.1542/peds.2016-3459. Epub 2017 Jun 7. — View Citation

National Statistical Office (NSO) [Malawi], ICF, Malawi Demographic and Health Survey 2015-16. Zomba, Malawi and Rockville, Maryland, USA: NSO and ICF; 2017.

Stewart CP, Caswell B, Iannotti L, Lutter C, Arnold CD, Chipatala R, Prado EL, Maleta K. The effect of eggs on early child growth in rural Malawi: the Mazira Project randomized controlled trial. Am J Clin Nutr. 2019 Oct 1;110(4):1026-1033. doi: 10.1093/aj — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plasma concentrations of micronutrient biomarkers (iron, zinc, vitamin A, B12) and lipids	Venous blood collection	6 months after the start of the intervention
Other	Microbiome: microbial diversity and abundance	Stool sample collection	Each month for 6 months
Primary	Length-for-age z-score	Child's recumbent length, standardized using the World Health Organization growth standards	6 months after the start of the intervention
Primary	Stunting	Prevalence of length-for-age z-score <-2	6 months after the start of the intervention
Secondary	Weight-for-age z-score and prevalence of underweight (WAZ<-2)		6 months after the start of the intervention
Secondary	Weight-for-length z-score and prevalence of wasting (WLZ<-2)		6 months after the start of the intervention
Secondary	Plasma choline concentration	Venous blood collection	6 months after the start of the intervention
Secondary	Plasma amino acid concentrations	Venous blood collection	6 months after the start of the intervention
Secondary	Cognitive development	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