NCT05168085

Brief Summary

This study will investigate the efficacy of providing one chicken egg per day for a period of 6 months, beginning at the age of 6 to \<9 months on the growth, motor development, micronutrient, and morbidity status of infants from a low socioeconomic community in South Africa.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
655

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 13, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

February 13, 2020

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

December 23, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 24, 2023

Status Verified

August 1, 2023

Enrollment Period

3.9 years

First QC Date

February 13, 2020

Last Update Submit

August 22, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Linear growth by measuring length

    Efficacy of providing one chicken egg per day on linear growth and stunting prevalence compare to a control

    6 months

Secondary Outcomes (3)

  • Motor development using Pictorial Gross Motor Milestone Chart

    6 months

  • Biomarkers of anaemia, iron, vitamin A and essential fatty acids

    6 months

  • Morbidity status

    6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

One chicken egg per day

Dietary Supplement: Eggs

Control group

NO INTERVENTION

True control

Interventions

EggsDIETARY_SUPPLEMENT

Providing 1 egg per day fo 6 months to infants

Intervention group

Eligibility Criteria

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

You may qualify if:

  • Resident in the study municipality; Infants aged 6 to \<9 months

You may not qualify if:

  • Severe obvious congenital abnormalities such as cleft lip and spina bifida; Severe anaemia (haemoglobin \<70 g/L); Severe acute malnutrition (weight-for-length z-score \< -3); Plans to move out of the study area in the next nine months; Known allergies/intolerances to eggs; Infants receiving special nutritional supplements as part of feeding programmes; Not been born as a singleton; Mother/legal guardian below 18 years old at the start of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jouberton area in the Matlosana sub-district

Klerksdorp, North West, 2574, South Africa

Location

Related Publications (2)

  • Nakiranda R, Malan L, Ricci H, Kruger HS, Nienaber A, Visser M, Ricci C, Faber M, Smuts CM. Daily Complementary Feeding With Eggs Improves Fibroblast Growth Factor 21 in Infants. Matern Child Nutr. 2025 Apr;21(2):e13782. doi: 10.1111/mcn.13782. Epub 2024 Dec 9.

  • Ricci H, Faber M, Ricci C, Kruger HS, Malan L, Nakiranda R, Visser M, Smuts CM. Effects of egg as an early complementary food on growth of 6- to 9-month-old infants: a randomised controlled trial. Public Health Nutr. 2023 Nov 29;27(1):e1. doi: 10.1017/S1368980023002604.

MeSH Terms

Interventions

Eggs

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Marius Smuts, PhD

    Director

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 13, 2020

First Posted

December 23, 2021

Study Start

February 13, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

August 24, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations