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

NCT ID: NCT03140696

Last Updated: 2021-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-30

Study Completion Date

2019-08-30

Brief Summary

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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

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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.

Conditions

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Protein Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Chicken egg alone

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

Group Type EXPERIMENTAL

Egg Alone

Intervention Type DIETARY_SUPPLEMENT

A chicken egg will be offered for 2 days

Egg and RUSF

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

Group Type EXPERIMENTAL

Egg and ready to use supplementary food (RUSF)

Intervention Type DIETARY_SUPPLEMENT

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

Egg and breast milk

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

Group Type EXPERIMENTAL

Egg and breast milk

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Egg Alone

A chicken egg will be offered for 2 days

Intervention Type DIETARY_SUPPLEMENT

Egg and ready to use supplementary food (RUSF)

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

Intervention Type DIETARY_SUPPLEMENT

Egg and breast milk

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

8 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Muttaquina Hossain, MPH

Role: PRINCIPAL_INVESTIGATOR

Research Investigator

Locations

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icddr,b Mirpur Field site

Dhaka, , Bangladesh

Site Status

Countries

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Bangladesh

Other Identifiers

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PR-16094

Identifier Type: -

Identifier Source: org_study_id