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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

655 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-13

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Linear Growth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention group

One chicken egg per day

Group Type EXPERIMENTAL

Eggs

Intervention Type DIETARY_SUPPLEMENT

Providing 1 egg per day fo 6 months to infants

Control group

True control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Eggs

Providing 1 egg per day fo 6 months to infants

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

6 Months

Maximum Eligible Age

9 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes