DEUX OEUFs: Cracking the Potential of Eggs to Improve Child Growth and Development

NCT06405360 | Active Not Recruiting DMC

• 1 other identifier: UFlorida 202301484
• Study Type: interventional
• Target: 464
• Locations: 1 country
• Sites: 1

Brief Summary

This proposed randomized controlled trial aims to investigate the effect of maternal egg consumption during pregnancy on birth length. The study hypothesizes that mothers who consume two eggs a day will have children whose birth length is significantly longer than those born to mothers who consume a typical diet. Pregnant women (n=956) from Nyagatare District in Rwanda will be randomized into one of two study arms: a treatment group (T1) or a control group (T2). Mothers in the treatment arm will receive an animal source food (ASF) supplement of two eggs per day, from enrollment during first trimester through childbirth. Mothers in the control arm will be asked to continue consuming their typical diet. Mothers in both arms will receive standard information, education, and communication about health and nutrition during pregnancy and after birth. All enrolled mothers in the study will also receive up- to-date standard care for pregnant women, as outlined by the Government of Rwanda, a fortified blended flour if they are not already receiving it from the government, a mobile phone with cellular connection, health insurance if they do not already have, and compensation for traveling to a Community Health Worker's home every day for study engagement. All women will receive ultrasound examinations three times during pregnancy, as well as blood tests for anemia. Women in the control arm will receive additional compensation at childbirth. Women will be recruited and enrolled during first trimester (9-14 weeks gestational age), as confirmed by ultrasound. At enrollment, baseline data will be collected on socio-economic factors, maternal health, maternal diet, and fetal growth. Additional markers for maternal health and child growth and development, including markers for fetal brain development, will be collected during two targeted ante-natal clinic visits (20-26 weeks and 30-34 weeks), where all women will receive ultrasound assessment in addition to their typical clinical assessment. At childbirth, maternal and child health data will be collected, including birth outcomes, child anthropometry, and indicators of neurodevelopment. Additional follow-up of maternal and child health indicators, including maternal depression, and infant and young child feeding practices, will be collected at 1 month and 6 months of child age.

Conditions

Infant Malnutrition; Fetal Growth Retardation

Keywords

Nutrition; Maternal Health; Infant growth and development; Maternal diet

Outcome Measures

Primary Outcomes (1)

• Newborn Length for age z-score

  Child's recumbent length at birth, standardized using the INTERGROWTH 21st growth standard

  Within 72 hours of birth

Secondary Outcomes (34)

• Head circumference Z-scores

  Between 20-26 weeks and 30-34 weeks gestational ages

• Femur length Z-scores

  Between 20-26 weeks and 30-34 weeks gestational ages

• Abdominal circumference Z-scores

  Between 20-26 weeks and 30-34 weeks gestational ages

• Biparietal Z-scores

  Between 20-26 weeks and 30-34 weeks gestational ages

• Estimated fetal weight Z-scores

  Between 20-26 weeks and 30-34 weeks gestational ages

Other Outcomes (9)

• Thalamus length

  Between 20-26 weeks and 30-34 weeks gestational ages

• Thalamus width

  Between 20-26 weeks and 30-34 weeks gestational ages

• Thalamus transverse

  Between 20-26 weeks and 30-34 weeks gestational ages

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Mothers in the intervention arm will receive an animal-source food supplement of two eggs per day from the day of enrollment during the first trimester through childbirth.

Dietary Supplement: Egg consumption

Control Arm

NO INTERVENTION

Mothers in the control arm will be asked to continue consuming their typical diet

Interventions

Egg consumption DIETARY_SUPPLEMENT

Participants in the intervention group will be provided two eggs to consume daily.

Intervention Arm

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Lives in study area (catchment area of Karangazi Health Center and Ndama Health Center)
• Confirmed viable intrauterine pregnancy (confirmed via ultrasound)
• Aged between 18-44 years
• weeks gestation (confirmed via ultrasound, up to 13 weeks +6 days)
• Agrees to participate with informed consent

You may not qualify if:

• Intention to move outside the study area in next 12 months
• Intention to deliver at a location outside of Eastern Province Nyagatare District
• Any known adverse reaction to eating eggs or porridge ingredients
• Any condition that could affect the ability to comply with the study requirements or understand the informed consent process
• Participation in other clinical trials (to avoid burden and potential interactions between interventions)
• Any individual unable or unwilling to comply with the study requirements, such as attending regular follow-up visits or adhering to prescribed nutritional supplementation.

Sponsors & Collaborators

• World Vision: collaborator
• University of Rwanda: collaborator
• University of Florida: lead

Study Sites (1)

Ndama Health Center

Nyagatare, Rwanda

Location

Related Publications (35)

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MeSH Terms

Conditions

Infant Nutrition Disorders; Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sarah McKune, PhD, MPH

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators and outcomes assessors will be blinded to the intervention arm once the participant is enrolled.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 8, 2024
• Study Start: May 2, 2024
• Primary Completion: October 30, 2025
• Study Completion: February 28, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 24 months after completion of the project
• Access Criteria: the de-identified data will be deposited into the Data Repository of the University of Florida and the USAID data repository, where it can be publicly accessed. Dataset in USAID repository will be findable and identifiable through a study digital object identifier (DOI).

Locations

RW (1)