Efficacy of Providing Eggs as an Early Complementary Food... | NCT05168085

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

NCT05168085

Sponsor

North-West University, South Africa

Status

Unknown status

Last Update Posted

Aug 24, 2023Actual

Enrollment

655Actual

Phase

Not Applicable

Conditions

Linear Growth

Interventions

Eggs

Countries

South Africa

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 13, 2020Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Feb 13, 2020

First Submission Date that Met QC Criteria

Dec 22, 2021

First Posted Date

Dec 23, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2023

Last Update Posted Date

Aug 24, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marius Smuts, Professor, North-West University, South AfricaPrincipal Investigator

Lead Sponsor

North-West University, South AfricaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

655Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention group	Experimental	One chicken egg per day	Dietary Supplement: Eggs
Control group	No Intervention	True control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Eggs	Dietary Supplement	Providing 1 egg per day fo 6 months to infants	Intervention group

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

9 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marius Smuts, PhD	Director	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jouberton area in the Matlosana sub-district		Klerksdorp	North West	2574	South Africa

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39648796	Derived	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.
38018158	Derived	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.

ID	Term
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D019602	Food and Beverages