Efficacy of Providing Eggs as an Early Complementary Food to Promote Child Growth

Randomised Controlled Trial to Test and Build Evidence Base for Providing Eggs as an Early Complementary Food to Promote Child Growth: Eggcel-growth Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Linear Growth
• Intervention / Treatment: Dietary supplement: Eggs

Detailed Description

The nutritional benefit of eggs, in particular chicken eggs is well documented. However, there is paucity of evidence regarding including eggs, in particular chicken eggs during the early complementary feeding phase to enhance child growth and development. Thus, this study seeks to determine and to provide evidence on the effectiveness of including chicken eggs as an early complementary food to enhance early child growth and development. This randomised controlled trial will contribute towards building a strong evidence for the promotion and use of eggs as a healthy and nutritious early complementary food, and can be used to inform future programming regarding infant and young child feeding in low- and middle-income countries.

This is a randomised controlled trial with a parallel design (2 groups). Five hundred infants aged 6 to <9 months will be included. Infants with egg allergy or sensitization will be excluded. Data will be collected in three months' interval for six months. At baseline, body measurements of mother and infant will be taken; infant's dietary intake using 24-hour recall methods; breastfeeding and complementary feeding practices; infant and maternal allergy and maternal depression with structured questionnaires. Morbidity symptoms and compliance will be recorded daily and followed up weekly. Developmental milestones will be assessed weekly using Pictorial Gross Motor Milestone Chart. Household food security will be assessed. Capillary blood will be collected by means of finger and/or heal prick. This will be a community driven project. Data will be analysed according to intention to treat.

• Study Type: Interventional
• Enrollment (Actual): 655
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • North West
    • Klerksdorp, North West, South Africa, 2574
      • Jouberton area in the Matlosana sub-district

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 9 months (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; One chicken egg per day	Dietary supplement: Eggs; Providing 1 egg per day fo 6 months to infants
No Intervention: Control group; True control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor development using Pictorial Gross Motor Milestone Chart	Effects of consuming one chicken egg per day on motor development compare to a control	6 months
Biomarkers of anaemia, iron, vitamin A and essential fatty acids	Effects of consuming one chicken egg per day on biochemical biomarkers compare to a control	6 months
Morbidity status	Effects of consuming one chicken egg per day on morbidity symptoms compare to a control	6 months

Collaborators and Investigators

• Sponsor: North-West University, South Africa
• Investigators: Principal Investigator: Marius Smuts, PhD, Director

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2020
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: February 13, 2020
• First Submitted That Met QC Criteria: December 22, 2021
• First Posted (Actual): December 23, 2021

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Eggcel-growth

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No