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

Linear Growth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05168085
• Other study ID #: Eggcel-growth
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 13, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2023
• Source: North-West University, South Africa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 655
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 9 Months

Eligibility

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

Related Conditions & MeSH terms

• Linear Growth

Intervention

Dietary Supplement:
• Eggs
Providing 1 egg per day fo 6 months to infants

Locations

Country	Name	City	State
South Africa	Jouberton area in the Matlosana sub-district	Klerksdorp	North West

Sponsors (1)

Lead Sponsor	Collaborator
North-West University, South Africa

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Morbidity status	Effects of consuming one chicken egg per day on morbidity symptoms compare to a control	6 months