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
NCT number | NCT03140696 |
Other study ID # | PR-16094 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 30, 2017 |
Est. completion date | August 30, 2019 |
Verified date | January 2021 |
Source | International Centre for Diarrhoeal Disease Research, Bangladesh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Bangladesh | icddr,b Mirpur Field site | Dhaka |
Lead Sponsor | Collaborator |
---|---|
International Centre for Diarrhoeal Disease Research, Bangladesh |
Bangladesh,
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 |
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