An interventional study of Eggs and Visits in Infant Malnutrition, sponsored by University of California, Davis. Completed at 1 site in Malawi. Open to participants aged 6 Months to 9 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-24.
Sponsored by University of California, Davis · Not applicable, Interventional, and Prevention
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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.
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.
67 studies on the registry are indexed under Infant Nutrition Disorders; 14 are open to participants now.
This study's enrollment of 662 is above the median of 180 across 46 interventional studies indexed under Infant Nutrition Disorders.
Browse Infant Nutrition Disorders studies →University of California, Davis is the lead sponsor of 810 studies on the registry; 142 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 43 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Behavioral: Visits
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
Eggs provided as complementary food for the infant
Twice weekly household visits by study staff
Length-for-age z-score
Child's recumbent length, standardized using the World Health Organization growth standards
Time frame: 6 months after the start of the intervention
Stunting
Prevalence of length-for-age z-score \<-2
Time frame: 6 months after the start of the intervention
Weight-for-age z-score and prevalence of underweight (WAZ<-2)
Time frame: 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
Plasma choline concentration
Venous blood collection
Time frame: 6 months after the start of the intervention
Plasma amino acid concentrations
Venous blood collection
Time frame: 6 months after the start of the intervention
Cognitive development
Measured using the Malawi Development Assessment Tool (MDAT), Infant eye-tracking measures of declarative memory, and delayed imitation tasks
Time frame: 6 months after the start of the intervention
Plasma concentrations of micronutrient biomarkers (iron, zinc, vitamin A, B12) and lipids
Venous blood collection
Time frame: 6 months after the start of the intervention
Microbiome: microbial diversity and abundance
Stool sample collection
Time frame: Each month for 6 months
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
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.
Access criteria: Published data will be made publicly accessible. Unpublished data may be requested by contacting the study Principal Investigator.
Data sharing details ↗ · osf.io
Ran from Jan 2018 to primary completion in Jan 2019, 12 months.
Of 25 interventional studies with no phase under Infant Nutrition Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 27. This study's 12 months is close to that.
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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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