The Mazira Project: An Evaluation of Eggs During Complementary Feeding in Rural Malawi
Primary Purpose
Infant Malnutrition
Status
Completed
Phase
Not Applicable
Locations
Malawi
Study Type
Interventional
Intervention
Eggs
Visits
Sponsored by
About this trial
This is an interventional prevention trial for Infant Malnutrition focused on measuring complementary feeding, eggs, infant growth, stunting, cognitive development, choline, vitamin B12, microbiome
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
Sites / Locations
- University of Malawi College of Medicine, Mangochi Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Egg Group
Control Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Length-for-age z-score
Child's recumbent length, standardized using the World Health Organization growth standards
Stunting
Prevalence of length-for-age z-score <-2
Secondary Outcome Measures
Weight-for-age z-score and prevalence of underweight (WAZ<-2)
Weight-for-length z-score and prevalence of wasting (WLZ<-2)
Plasma choline concentration
Venous blood collection
Plasma amino acid concentrations
Venous blood collection
Cognitive development
Measured using the Malawi Development Assessment Tool (MDAT), Infant eye-tracking measures of declarative memory, and delayed imitation tasks
Full Information
NCT ID
NCT03385252
First Posted
December 20, 2017
Last Updated
February 20, 2020
Sponsor
University of California, Davis
Collaborators
Kamuzu University of Health Sciences, Washington University School of Medicine, University of Maryland, College Park
1. Study Identification
Unique Protocol Identification Number
NCT03385252
Brief Title
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
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 22, 2018 (Actual)
Primary Completion Date
January 22, 2019 (Actual)
Study Completion Date
January 22, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
Kamuzu University of Health Sciences, Washington University School of Medicine, University of Maryland, College Park
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant Malnutrition
Keywords
complementary feeding, eggs, infant growth, stunting, cognitive development, choline, vitamin B12, microbiome
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Participants will not be masked. Data collectors will not be informed of the participant's group assignments. Data analysis will be conducted on blinded datasets until the primary analysis is complete.
Allocation
Randomized
Enrollment
662 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Egg Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Eggs
Intervention Description
Eggs provided as complementary food for the infant
Intervention Type
Behavioral
Intervention Name(s)
Visits
Intervention Description
Twice weekly household visits by study staff
Primary Outcome Measure Information:
Title
Length-for-age z-score
Description
Child's recumbent length, standardized using the World Health Organization growth standards
Time Frame
6 months after the start of the intervention
Title
Stunting
Description
Prevalence of length-for-age z-score <-2
Time Frame
6 months after the start of the intervention
Secondary Outcome Measure Information:
Title
Weight-for-age z-score and prevalence of underweight (WAZ<-2)
Time Frame
6 months after the start of the intervention
Title
Weight-for-length z-score and prevalence of wasting (WLZ<-2)
Time Frame
6 months after the start of the intervention
Title
Plasma choline concentration
Description
Venous blood collection
Time Frame
6 months after the start of the intervention
Title
Plasma amino acid concentrations
Description
Venous blood collection
Time Frame
6 months after the start of the intervention
Title
Cognitive development
Description
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
Other Pre-specified Outcome Measures:
Title
Plasma concentrations of micronutrient biomarkers (iron, zinc, vitamin A, B12) and lipids
Description
Venous blood collection
Time Frame
6 months after the start of the intervention
Title
Microbiome: microbial diversity and abundance
Description
Stool sample collection
Time Frame
Each month for 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
9 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine P Stewart, PhD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lora Iannotti, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chessa Lutter, PhD
Organizational Affiliation
University of Maryland, College Park
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kenneth M Maleta, PhD
Organizational Affiliation
Kamuzu University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Malawi College of Medicine, Mangochi Campus
City
Mangochi
Country
Malawi
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
https://osf.io/vfrg7/
Citations:
Citation
National Statistical Office (NSO) [Malawi], ICF, Malawi Demographic and Health Survey 2015-16. Zomba, Malawi and Rockville, Maryland, USA: NSO and ICF; 2017.
Results Reference
background
PubMed Identifier
28588101
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.
Results Reference
background
PubMed Identifier
31386106
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.
Results Reference
result
PubMed Identifier
35755939
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.
Results Reference
derived
PubMed Identifier
35233478
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.
Results Reference
derived
PubMed Identifier
33974324
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.
Results Reference
derived
PubMed Identifier
33128502
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.
Results Reference
derived
PubMed Identifier
32286620
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.
Results Reference
derived
Learn more about this trial
The Mazira Project: An Evaluation of Eggs During Complementary Feeding in Rural Malawi
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