Linear GrowthNCT05168085
Efficacy of Providing Eggs as an Early Complementary Food to Promote Child Growth
A study testing Eggs in people with Linear Growth, run by North-West University, South Africa at 1 site in South Africa.
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. Read more about this study
- Who is it for?
- Ages 6 to 9 monthsHealthy volunteers can take part
- Conditions the study is for
- Linear Growth
- What is being tested?
- Eggs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 655 participants
- Where
- 1 siteSouth Africa
- Study dates
- 13 Feb 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Resident in the study municipality; Infants aged 6 to <9 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Jouberton area in the Matlosana sub-district
Klerksdorp, North West, 2574
About this study
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
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.
Read the 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.
- Conditions
- Linear Growth
- Being tested
- Eggs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EggsDietary supplement
Providing 1 egg per day fo 6 months to infants
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | One chicken egg per day Receives: Dietary Supplement: Eggs |
| Control group | No intervention | True control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear growth by measuring length
Efficacy of providing one chicken egg per day on linear growth and stunting prevalence compare to a control
Measured: 6 months
Secondary outcomes (3)
Motor development using Pictorial Gross Motor Milestone Chart
Effects of consuming one chicken egg per day on motor development compare to a control
Measured: 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
Measured: 6 months
Morbidity status
Effects of consuming one chicken egg per day on morbidity symptoms compare to a control
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start13 Feb 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Linear GrowthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 655 participants (actual)
Sponsor and investigators
- Lead sponsor
- North-West University, South Africa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marius Smuts, North-West University, South Africa
- Investigators
- Marius Smuts, PhD, Principal investigator, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168085
- Sponsor's protocol ID
- Eggcel-growth
- Status last verified
- Aug 2023
- First submitted
- 13 Feb 2020
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39648796Ricci 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.
PubMed 38018158
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05168085
- Acronym / sponsor ID
- Eggcel-growth
- Conditions
- Linear Growth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 655 participants (actual)
- Lead sponsor
- North-West University, South AfricaUniversity, hospital or other
- Study start
- 13 Feb 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 23 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: EggsOne chicken egg per day |
| Control group | No intervention | –True control |
Who may qualify
- Ages
- 6 to 9 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Resident in the study municipality; Infants aged 6 to <9 months
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EggsProviding 1 egg per day fo 6 months to infants | Dietary supplement | Intervention group |
Primary outcome
Linear growth by measuring length
Time frame: 6 months
Efficacy of providing one chicken egg per day on linear growth and stunting prevalence compare to a control
3 secondary outcomes
Motor development using Pictorial Gross Motor Milestone Chart
Time frame: 6 months
Biomarkers of anaemia, iron, vitamin A and essential fatty acids
Time frame: 6 months
Morbidity status
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Derived from this study: PubMed 39648796Nakiranda 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.
- Derived from this study: PubMed 38018158Ricci 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marius Smuts, PhD principal investigator
Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eggs in people with Linear Growth, run by North-West University, South Africa at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linear growth by measuring length (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05168085, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.