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

Protein Malnutrition Clinical Trial

Official title:

Formative Research on the Use of Egg as a Nutritional Supplement for Young Bangladeshi Children and Breast Milk Nutrient Content of Bangladeshi Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03140696
• Other study ID #: PR-16094
• Status: Completed
• Phase: N/A
• Start date: March 30, 2017
• Est. completion date: August 30, 2019

Study information

• Verified date: January 2021
• Source: International Centre for Diarrhoeal Disease Research, Bangladesh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 8 Months

Eligibility

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

Related Conditions & MeSH terms

• Kwashiorkor
• Malnutrition
• Protein Malnutrition

Intervention

Dietary Supplement:
• Egg Alone
A chicken egg will be offered for 2 days
• Egg and ready to use supplementary food (RUSF)
A chicken egg and ready to use supplementary food (RUSF) will be offered for 2 days
• Egg and breast milk
A chicken egg and breast milk will be offered for 2 days

Locations

Country	Name	City	State
Bangladesh	icddr,b Mirpur Field site	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
International Centre for Diarrhoeal Disease Research, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ideal mode of feeding egg to young infants 6-8 months of age	Each of the diets (egg alone or egg + RUSF or egg + breast milk) will be offered for 2 days each. The order of diets will be randomly allocated over a period of 6 days.On the first day, the child will be acclimatized with the given regime, and on second day, the mother will be asked to rate the offered food by using a 7-point Hedonic Scale in terms of colour, flavour, appearance and overall liking. A fixed amount of food will be offered. The food offered would be weighed before consumption and the left over will also be weighed to measure the actual amount of food consumed by the children. Total amount of offered food taken by the children will also be recorded. During the feeding time, field research assistants will observe the feeding session by using a structured tool. This combined approach (Hedonic scale and amount of food taken) will be used to determine the ideal mode of feeding of an egg by young infants.	2 days