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

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

Sponsors

Lead Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh

Source International Centre for Diarrhoeal Disease Research, Bangladesh
Brief 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.

Detailed 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.

Overall Status Recruiting
Start Date March 10, 2017
Completion Date March 31, 2020
Primary Completion Date March 31, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Ideal mode of feeding egg to young infants 6-8 months of age 2 days
Enrollment 30
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Egg Alone

Description: A chicken egg will be offered for 2 days

Arm Group Label: Chicken egg alone

Intervention Type: Dietary Supplement

Intervention Name: Egg and ready to use supplementary food (RUSF)

Description: A chicken egg and ready to use supplementary food (RUSF) will be offered for 2 days

Arm Group Label: Egg and RUSF

Intervention Type: Dietary Supplement

Intervention Name: Egg and breast milk

Description: A chicken egg and breast milk will be offered for 2 days

Arm Group Label: Egg and breast milk

Eligibility

Criteria:

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

Gender: All

Minimum Age: 6 Months

Maximum Age: 8 Months

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Muttaquina Hossain, MPH Principal Investigator Research Investigator
Overall Contact

Last Name: Muttaquina Hossain, MPH

Phone: (+88 02) 9827001-10

Phone Ext.: 2282

Email: [email protected]

Location
Facility: Status: Contact: icddr,b Mirpur Field site Muttaquina Hossain, MBBS, MPH 880-2-9827101-10 2282 [email protected]
Location Countries

Bangladesh

Verification Date

May 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Chicken egg alone

Type: Experimental

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

Label: Egg and RUSF

Type: Experimental

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

Label: Egg and breast milk

Type: Experimental

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Intervention Model Description: The children will be randomly allocated to one of the three types of food (egg alone or egg + RUSF or egg + breast milk) in a crossover design. 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. There would be 6 possible permutations and combinations of the order of the diets over this 6 days sequential period.

Primary Purpose: Basic Science

Masking: None (Open Label)

Source: ClinicalTrials.gov