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

NCT03140696 | Completed

• 1 other identifier: PR-16094
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Protein Malnutrition

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Chicken egg alone

EXPERIMENTAL

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

Dietary Supplement: Egg Alone

Egg and RUSF

EXPERIMENTAL

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

Dietary Supplement: Egg and ready to use supplementary food (RUSF)

Egg and breast milk

EXPERIMENTAL

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

Dietary Supplement: Egg and breast milk

Interventions

Egg Alone DIETARY_SUPPLEMENT

A chicken egg will be offered for 2 days

Chicken egg alone

Egg and ready to use supplementary food (RUSF) DIETARY_SUPPLEMENT

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

Egg and RUSF

Egg and breast milk DIETARY_SUPPLEMENT

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

Egg and breast milk

Eligibility Criteria

• Age: 6 Months - 8 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• (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

You may not qualify if:

• Children whose parents/caregivers refuse to provide informed consent will not be enrolled

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead

Study Sites (1)

icddr,b Mirpur Field site

Dhaka, 1212, Bangladesh

Location

MeSH Terms

Conditions

Kwashiorkor

Interventions

Eggs; Milk, Human

Condition Hierarchy (Ancestors)

Severe Acute Malnutrition; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Milk; Beverages; Dairy Products

Study Officials

• Muttaquina Hossain, MPH

  Research Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 4, 2017
• Study Start: March 30, 2017
• Primary Completion: June 30, 2019
• Study Completion: August 30, 2019
• Last Updated: October 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)