NCT03385252

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
662

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 28, 2017

Completed
25 days until next milestone

Study Start

First participant enrolled

January 22, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2019

Completed
Last Updated

February 24, 2020

Status Verified

February 1, 2020

Enrollment Period

1 year

First QC Date

December 20, 2017

Last Update Submit

February 20, 2020

Conditions

Infant Malnutrition

Keywords

complementary feedingeggsinfant growthstuntingcognitive developmentcholinevitamin B12microbiome

Outcome Measures

Primary Outcomes (2)

  • 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

  • Stunting

    Prevalence of length-for-age z-score \<-2

    6 months after the start of the intervention

Secondary Outcomes (5)

  • Weight-for-age z-score and prevalence of underweight (WAZ<-2)

    6 months after the start of the intervention

  • Weight-for-length z-score and prevalence of wasting (WLZ<-2)

    6 months after the start of the intervention

  • Plasma choline concentration

    6 months after the start of the intervention

  • Plasma amino acid concentrations

    6 months after the start of the intervention

  • Cognitive development

    6 months after the start of the intervention

Other Outcomes (2)

  • Plasma concentrations of micronutrient biomarkers (iron, zinc, vitamin A, B12) and lipids

    6 months after the start of the intervention

  • Microbiome: microbial diversity and abundance

    Each month for 6 months

Study Arms (2)

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.

Other: EggsBehavioral: 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.

Behavioral: Visits

Interventions

EggsOTHER

Eggs provided as complementary food for the infant

Egg Group
VisitsBEHAVIORAL

Twice weekly household visits by study staff

Control GroupEgg Group

Eligibility Criteria

Age6 Months - 9 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Living in catchment area of Lungwena health center, Mangochi District, Malawi during the study enrollment period
  • Singleton birth

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Malawi College of Medicine, Mangochi Campus

Mangochi, Malawi

Location

Related Publications (9)

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

    BACKGROUND

  • 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.

    PMID: 28588101BACKGROUND

  • 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.

    PMID: 31386106RESULT

  • Werner 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.

    PMID: 37181936DERIVED

  • 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.

    PMID: 35755939DERIVED

  • 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.

    PMID: 35233478DERIVED

  • 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.

    PMID: 33974324DERIVED

  • 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.

    PMID: 33128502DERIVED

  • 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.

    PMID: 32286620DERIVED

MeSH Terms

Conditions

Infant Nutrition DisordersGrowth Disorders

Interventions

Eggs

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Christine P Stewart, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

  • Lora Iannotti, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

  • Chessa Lutter, PhD

    University of Maryland, College Park

    PRINCIPAL INVESTIGATOR

  • Kenneth M Maleta, PhD

    Kamuzu University of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2017

First Posted

December 28, 2017

Study Start

January 22, 2018

Primary Completion

January 22, 2019

Study Completion

January 22, 2019

Last Updated

February 24, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, 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.
More information

Locations

MA(1)