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

Primary Purpose

Protein Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Egg Alone
Egg and ready to use supplementary food (RUSF)
Egg and breast milk
Sponsored by
International Centre for Diarrhoeal Disease Research, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Protein Malnutrition

Eligibility Criteria

6 Months - 8 Months (Child)All SexesDoes not accept 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

Sites / Locations

  • icddr,b Mirpur Field site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Chicken egg alone

Egg and RUSF

Egg and breast milk

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 2, 2017
Last Updated
October 25, 2021
Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
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1. Study Identification

Unique Protocol Identification Number
NCT03140696
Brief Title
Formative Research Study to Address Protein Intake in Children and Analysis of Breast Milk Nutrient Content in Mothers
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 30, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Protein Malnutrition

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chicken egg alone
Arm Type
Experimental
Arm Description
A chicken egg alone will be offered for 2 days by mouth for once a day
Arm Title
Egg and RUSF
Arm Type
Experimental
Arm Description
A chicken egg and Ready to use supplementary food (RUSF) will be offered for 2 days by mouth for once a day
Arm Title
Egg and breast milk
Arm Type
Experimental
Arm Description
A chicken egg and Mother's breast milk will be offered for 2 days by mouth for once a day
Intervention Type
Dietary Supplement
Intervention Name(s)
Egg Alone
Intervention Description
A chicken egg will be offered for 2 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Egg and ready to use supplementary food (RUSF)
Intervention Description
A chicken egg and ready to use supplementary food (RUSF) will be offered for 2 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Egg and breast milk
Intervention Description
A chicken egg and breast milk will be offered for 2 days
Primary Outcome Measure Information:
Title
Ideal mode of feeding egg to young infants 6-8 months of age
Description
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.
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
8 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muttaquina Hossain, MPH
Organizational Affiliation
Research Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
icddr,b Mirpur Field site
City
Dhaka
ZIP/Postal Code
1212
Country
Bangladesh

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The data will be entirely a property of organization and will be under lock and key under Principal Investigator. No participant data will make available to public without participants concents

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

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