Infant MalnutritionNCT03385252
The Mazira Project: An Evaluation of Eggs During Complementary Feeding in Rural Malawi
A study testing Eggs and Visits in people with Infant Malnutrition, run by University of California, Davis at 1 site in Malawi.
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. Read more about this study
- Who is it for?
- Ages 6 to 9 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Malnutrition
- What is being tested?
- Eggs and Visits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 662 participants
- Where
- 1 siteMalawi
- Study dates
- 22 Jan 2018to 22 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Living in catchment area of Lungwena health center, Mangochi District, Malawi during the study enrollment period
- Singleton birth
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malawi1 site
University of Malawi College of Medicine, Mangochi Campus
Mangochi
About this study
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.
Read the 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.
- Conditions
- Infant Malnutrition
- Being tested
- Eggs, Visits
- Keywords
- complementary feeding, eggs, infant growth, stunting, cognitive development, choline, vitamin B12, microbiome
- Medical subject headings
- Infant Nutrition Disorders, Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EggsOther
Eggs provided as complementary food for the infant
VisitsBehavioural
Twice weekly household visits by study staff
| Study group | Role | What they receive |
|---|---|---|
| Egg Group | Experimental | 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. Receives: Other: Eggs; Behavioral: Visits |
| Control Group | Active comparator | 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. Receives: Behavioral: Visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length-for-age z-score
Child's recumbent length, standardized using the World Health Organization growth standards
Measured: 6 months after the start of the intervention
Stunting
Prevalence of length-for-age z-score <-2
Measured: 6 months after the start of the intervention
Secondary outcomes (5)
Weight-for-age z-score and prevalence of underweight (WAZ<-2)
Measured: 6 months after the start of the intervention
Weight-for-length z-score and prevalence of wasting (WLZ<-2)
Measured: 6 months after the start of the intervention
Plasma choline concentration
Venous blood collection
Measured: 6 months after the start of the intervention
Plasma amino acid concentrations
Venous blood collection
Measured: 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
Measured: 6 months after the start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study start22 Jan 2018
- Primary completion22 Jan 2019
- Study completion22 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Infant MalnutritionStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 662 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Kamuzu University of Health Sciences, Washington University School of Medicine, University of Maryland, College Park
- Responsible party
- Sponsor
- Investigators
- Christine P Stewart, PhD, Principal investigator, University of California, DavisLora Iannotti, PhD, Principal investigator, Washington University School of MedicineChessa Lutter, PhD, Principal investigator, University of Maryland, College ParkKenneth M Maleta, PhD, Principal investigator, Kamuzu University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385252
- Sponsor's protocol ID
- 1125193
- Status last verified
- Feb 2020
- First submitted
- 20 Dec 2017
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
National Statistical Office (NSO) [Malawi], ICF, Malawi Demographic and Health Survey 2015-16. Zomba, Malawi and Rockville, Maryland, USA: NSO and ICF; 2017.
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.
PubMed 28588101Stewart 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.
PubMed 31386106Rianda D, Oakes LM, Arnold CD, DeBolt MC, George M, Beckner AG, Maleta KM, Smilowitz JT, Stewart CP. Growth trajectories and early-life attention and memory outcomes: Parallel analyses of cohorts in Malawi and the USA. Am J Clin Nutr. 2026 Aug 29:101509. doi: 10.1016/j.ajcnut.2026.101509. Online ahead of print.
PubMed 42668044Werner ER, Haskell MJ, Arnold CD, Caswell BL, Iannotti LL, Lutter CK, Maleta KM, Stewart CP. The Effects of One Egg Per Day on Vitamin A Status Among Young Malawian Children: A Secondary Analysis of a Randomized Controlled Trial. Curr Dev Nutr. 2023 Feb 23;7(3):100053. doi: 10.1016/j.cdnut.2023.100053. eCollection 2023 Mar.
PubMed 37181936Werner 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.
PubMed 35755939Bragg 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.
PubMed 35233478Caswell 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.
PubMed 33974324Lutter 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.
PubMed 33128502Prado 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.
PubMed 32286620
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mazira Project: An Evaluation of Eggs During Complementary Feeding in Rural Malawi
- ClinicalTrials.gov ID
- NCT03385252
- Acronym / sponsor ID
- 1125193
- Conditions
- Infant Malnutrition
- Keywords
- complementary feeding, eggs, infant growth, stunting, cognitive development, choline, vitamin B12, microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 662 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Kamuzu University of Health Sciences, Washington University School of Medicine, University of Maryland, College Park
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 22 Jan 2019 (actual)
- Study completion
- 22 Jan 2019 (actual)
- First posted
- 28 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Egg Group | Experimental | Other: Eggs, Behavioral: VisitsEgg 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 | Active comparator | Behavioral: VisitsControl 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. |
Who may qualify
- Ages
- 6 to 9 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Living in catchment area of Lungwena health center, Mangochi District, Malawi during the study enrollment period
- Singleton birth
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EggsEggs provided as complementary food for the infant | Other | Egg Group |
| VisitsTwice weekly household visits by study staff | Behavioural | Control Group, Egg Group |
Primary outcome
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
Stunting
Time frame: 6 months after the start of the intervention
Prevalence of length-for-age z-score <-2
5 secondary outcomes
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
Time frame: 6 months after the start of the intervention
Plasma amino acid concentrations
Time frame: 6 months after the start of the intervention
Cognitive development
Time frame: 6 months after the start of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- BackgroundNational Statistical Office (NSO) [Malawi], ICF, Malawi Demographic and Health Survey 2015-16. Zomba, Malawi and Rockville, Maryland, USA: NSO and ICF; 2017.
- Background: PubMed 28588101Iannotti 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 publication: PubMed 31386106Stewart 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.
- Derived from this study: PubMed 42668044Rianda D, Oakes LM, Arnold CD, DeBolt MC, George M, Beckner AG, Maleta KM, Smilowitz JT, Stewart CP. Growth trajectories and early-life attention and memory outcomes: Parallel analyses of cohorts in Malawi and the USA. Am J Clin Nutr. 2026 Aug 29:101509. doi: 10.1016/j.ajcnut.2026.101509. Online ahead of print.
- Derived from this study: PubMed 37181936Werner ER, Haskell MJ, Arnold CD, Caswell BL, Iannotti LL, Lutter CK, Maleta KM, Stewart CP. The Effects of One Egg Per Day on Vitamin A Status Among Young Malawian Children: A Secondary Analysis of a Randomized Controlled Trial. Curr Dev Nutr. 2023 Feb 23;7(3):100053. doi: 10.1016/j.cdnut.2023.100053. eCollection 2023 Mar.
- Derived from this study: PubMed 35755939Werner 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.
- Derived from this study: PubMed 35233478Bragg 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.
- Derived from this study: PubMed 33974324Caswell 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.
- Derived from this study: PubMed 33128502Lutter 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.
- Derived from this study: PubMed 32286620Prado 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine P Stewart, PhD principal investigator
University of California, Davis
Lora Iannotti, PhD principal investigator
Washington University School of Medicine
Chessa Lutter, PhD principal investigator
University of Maryland, College Park
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eggs and Visits in people with Infant Malnutrition, run by University of California, Davis at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length-for-age z-score (time frame: 6 months after the start of the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03385252, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2020.