Formative Research Study to Address Protein Intake in Children and Analysis of Breast Milk Nutrient Content in Mothers

International Centre for Diarrhoeal Disease Research (icddr,b)

Status: Completed

Conditions: Protein Malnutrition

Treatments: Dietary Supplement: Egg and ready to use supplementary food (RUSF); Dietary Supplement: Egg and breast milk; Dietary Supplement: Egg Alone

Study type: Interventional

Funder types: Other

Identifiers

NCT03140696

PR-16094

Details and patient eligibility

About

This formative research seeks to explore the use of egg (as a potential source of protein) as nutritional supplement for young children aged 6-8 months of either sex and breast milk composition of mothers of infants under 6 months old living in an urban slum of Dhaka city, Bangladesh.

Full description

Inadequate dietary protein intake and prolonged undernourishment can lead to short term and long-term consequences, which can deplete financial, physical, and social capital, further exacerbating the cycle of undernutrition. Subsequently, undernutrition contributes to the difficulty in achieving sustainable development and alleviating people from poverty. Children are a particular focus of interest because of the formative impact that nutrition can have on development. This is particularly relevant for the 159 million children from low and middle-income countries (LMICs) who are already stunted and many more are at risk of stunting. Understanding how to prevent child undernutrition is imperative to the future development of these children from LMICs. There is no study done so far to understand the quantity, preference and quality of egg protein intake in young children living in LMICs with high burden of undernutrition. In this context, eggs can serve as a potential source of protein to meet the unmet need of protein especially children living in resource-poor environments. Eggs contain high concentrations of choline - an important precursor of phospholipids, which can prevent adverse pregnancy outcomes, neural tube defects, changes in brain structure and function in offspring, and impaired language development during early childhood. Evidence is limited on the support of egg-related interventions for better nutrition outcomes in children from developing countries. Also there is very little evidence on the association between mother's breast milk composition with child's nutritional status.

Enrollment: 30 patients

Sex: All

Ages: 6 to 8 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

(i) consuming complementary food (liquid or semi-solid or solid food) other than breast milk at least once daily; (ii) free from any acute or chronic illness (es); (iii) no known case of congenital abnormality or chromosomal disorder, and (iii) no history of micro-nutrient or food supplementation in last two weeks prior to enrollment (iv) should be breastfed but not exclusively breastfed

Exclusion criteria

• Children whose parents/caregivers refuse to provide informed consent will not be enrolled

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

30 participants in 3 patient groups

Chicken egg alone

Experimental group

Description:

A chicken egg alone will be offered for 2 days by mouth for once a day

Treatment:

Dietary Supplement: Egg Alone

Egg and RUSF

Experimental group

Description:

A chicken egg and Ready to use supplementary food (RUSF) will be offered for 2 days by mouth for once a day

Treatment:

Dietary Supplement: Egg and ready to use supplementary food (RUSF)

Egg and breast milk

Experimental group

Description:

A chicken egg and Mother's breast milk will be offered for 2 days by mouth for once a day

Treatment:

Dietary Supplement: Egg and breast milk