Clinical trial NCT05168085: Efficacy of Providing Eggs as an Early Complementary Food to Promote Child Growth
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Linear Growth
Lead sponsor: North-West University, South Africa
Sponsor class: OTHER
First posted: 2021-12-23
Enrollment: 655
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Linear growth by measuring length
timeFrame: 6 months
Secondary outcomes:
measure: Motor development using Pictorial Gross Motor Milestone Chart
timeFrame: 6 months
measure: Biomarkers of anaemia, iron, vitamin A and essential fatty acids
timeFrame: 6 months
measure: Morbidity status
timeFrame: 6 months
Other outcomes:
Locations:
city: Klerksdorp
country: South Africa
facility: Jouberton area in the Matlosana sub-district
state: North West
Study officials:
affiliation: Director
name: Marius Smuts, PhD
role: PRINCIPAL_INVESTIGATOR
References: