Trials / Unknown
UnknownNCT05168085
Efficacy of Providing Eggs as an Early Complementary Food to Promote Child Growth
Randomised Controlled Trial to Test and Build Evidence Base for Providing Eggs as an Early Complementary Food to Promote Child Growth: Eggcel-growth Study
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 655 (actual)
- Sponsor
- North-West University, South Africa · Academic / Other
- Sex
- All
- Age
- 6 Months – 9 Months
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Eggs | Providing 1 egg per day fo 6 months to infants |
Timeline
- Start date
- 2020-02-13
- Primary completion
- 2023-12-31
- Completion
- 2023-12-31
- First posted
- 2021-12-23
- Last updated
- 2023-08-24
Locations
1 site across 1 country: South Africa
Source: ClinicalTrials.gov record NCT05168085. Inclusion in this directory is not an endorsement.