Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 252 for:    Active, not recruiting Studies | ( Map: South Africa )
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05168085
Recruitment Status : Active, not recruiting
First Posted : December 23, 2021
Last Update Posted : March 3, 2022
Sponsor:
Information provided by (Responsible Party):
Marius Smuts, North-West University, South Africa

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.

Condition or disease Intervention/treatment Phase
Linear Growth Dietary Supplement: Eggs Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 13, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
Experimental: Intervention group
One chicken egg per day
Dietary Supplement: Eggs
Providing 1 egg per day fo 6 months to infants

No Intervention: Control group
True control



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Motor development using Pictorial Gross Motor Milestone Chart [ Time Frame: 6 months ]
    Effects of consuming one chicken egg per day on motor development compare to a control

  2. Biomarkers of anaemia, iron, vitamin A and essential fatty acids [ Time Frame: 6 months ]
    Effects of consuming one chicken egg per day on biochemical biomarkers compare to a control

  3. Morbidity status [ Time Frame: 6 months ]
    Effects of consuming one chicken egg per day on morbidity symptoms compare to a control



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Months to 9 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05168085


Locations
Layout table for location information
South Africa
Jouberton area in the Matlosana sub-district
Klerksdorp, North West, South Africa, 2574
Sponsors and Collaborators
North-West University, South Africa
Investigators
Layout table for investigator information
Principal Investigator: Marius Smuts, PhD Director
Layout table for additonal information
Responsible Party: Marius Smuts, Professor, North-West University, South Africa
ClinicalTrials.gov Identifier: NCT05168085    
Other Study ID Numbers: Eggcel-growth
First Posted: December 23, 2021    Key Record Dates
Last Update Posted: March 3, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No