Clinical trial NCT03385252: The Mazira Project: An Evaluation of Eggs During Complementary Feeding in Rural Malawi
Official title: The Mazira Project: An Evaluation of Eggs During Complementary Feeding in Rural Malawi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Malnutrition
Keywords: complementary feeding
eggs
infant growth
stunting
cognitive development
choline
vitamin B12
microbiome
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Kamuzu University of Health Sciences
name: Washington University School of Medicine
name: University of Maryland, College Park
First posted: 2017-12-28
Enrollment: 662
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Length-for-age z-score
timeFrame: 6 months after the start of the intervention
measure: Stunting
timeFrame: 6 months after the start of the intervention
Secondary outcomes:
measure: Weight-for-age z-score and prevalence of underweight (WAZ<-2)
timeFrame: 6 months after the start of the intervention
measure: Weight-for-length z-score and prevalence of wasting (WLZ<-2)
timeFrame: 6 months after the start of the intervention
measure: Plasma choline concentration
timeFrame: 6 months after the start of the intervention
measure: Plasma amino acid concentrations
timeFrame: 6 months after the start of the intervention
measure: Cognitive development
timeFrame: 6 months after the start of the intervention
Other outcomes:
measure: Plasma concentrations of micronutrient biomarkers (iron, zinc, vitamin A, B12) and lipids
timeFrame: 6 months after the start of the intervention
measure: Microbiome: microbial diversity and abundance
timeFrame: Each month for 6 months
Locations:
city: Mangochi
country: Malawi
facility: University of Malawi College of Medicine, Mangochi Campus
Study officials:
affiliation: University of California, Davis
name: Christine P Stewart, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Lora Iannotti, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland, College Park
name: Chessa Lutter, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kamuzu University of Health Sciences
name: Kenneth M Maleta, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: National Statistical Office (NSO) [Malawi], ICF, Malawi Demographic and Health Survey 2015-16. Zomba, Malawi and Rockville, Maryland, USA: NSO and ICF; 2017.
citation: Iannotti LL, Lutter CK, Stewart CP, Gallegos Riofrio 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):e20163459. doi: 10.1542/peds.2016-3459. Epub 2017 Jun 7.
citation: 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/ajcn/nqz163.
citation: Werner ER, Arnold CD, Caswell BL, Iannotti LL, Lutter CK, Maleta KM, Stewart CP. The Effects of 1 Egg per Day on Iron and Anemia Status among Young Malawian Children: A Secondary Analysis of a Randomized Controlled Trial. Curr Dev Nutr. 2022 May 13;6(6):nzac094. doi: 10.1093/cdn/nzac094. eCollection 2022 Jun.
citation: Bragg MG, Prado EL, Arnold CD, Zyba SJ, Maleta KM, Caswell BL, Bennett BJ, Iannotti LL, Lutter CK, Stewart CP. Plasma Choline Concentration Was Not Increased After a 6-Month Egg Intervention in 6-9-Month-Old Malawian Children: Results from a Randomized Controlled Trial. Curr Dev Nutr. 2022 Feb 23;6(2):nzab150. doi: 10.1093/cdn/nzab150. eCollection 2022 Feb.
citation: Caswell BL, Arnold CD, Lutter CK, Iannotti LL, Chipatala R, Werner ER, Maleta KM, Stewart CP. Impacts of an egg intervention on nutrient adequacy among young Malawian children. Matern Child Nutr. 2021 Jul;17(3):e13196. doi: 10.1111/mcn.13196. Epub 2021 May 11.
citation: Lutter CK, Caswell BL, Arnold CD, Iannotti LL, Maleta K, Chipatala R, Prado EL, Stewart CP. Impacts of an egg complementary feeding trial on energy intake and dietary diversity in Malawi. Matern Child Nutr. 2021 Jan;17(1):e13055. doi: 10.1111/mcn.13055. Epub 2020 Jul 20.
citation: Prado EL, Maleta K, Caswell BL, George M, Oakes LM, DeBolt MC, Bragg MG, Arnold CD, Iannotti LL, Lutter CK, Stewart CP. Early Child Development Outcomes of a Randomized Trial Providing 1 Egg Per Day to Children Age 6 to 15 Months in Malawi. J Nutr. 2020 Jul 1;150(7):1933-1942. doi: 10.1093/jn/nxaa088.