Protein MalnutritionNCT03140696
Formative Research Study to Address Protein Intake in Children and Analysis of Breast Milk Nutrient Content in Mothers
A study testing Egg Alone, Egg and ready to use supplementary food (RUSF) and Egg and breast milk in people with Protein Malnutrition, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 8 months
- Conditions the study is for
- Protein Malnutrition
- What is being tested?
- Egg Alone, Egg and ready to use supplementary food (RUSF) and Egg and breast milk
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBangladesh
- Study dates
- 30 Mar 2017to 30 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 8 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Children whose parents/caregivers refuse to provide informed consent will not be enrolled
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Protein Malnutrition
- Being tested
- Egg Alone, Egg and ready to use supplementary food (RUSF), Egg and breast milk
- Medical subject headings
- Kwashiorkor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Egg AloneDietary supplement
A chicken egg will be offered for 2 days
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 breast milkDietary supplement
A chicken egg and breast milk will be offered for 2 days
| Study group | Role | What they receive |
|---|---|---|
| Chicken egg alone | Experimental | A chicken egg alone will be offered for 2 days by mouth for once a day Receives: 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 Receives: 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 Receives: Dietary Supplement: Egg and breast milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start30 Mar 2017
- Primary completion30 Jun 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protein MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muttaquina Hossain, MPH, Principal investigator, Research Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140696
- Sponsor's protocol ID
- PR-16094
- Status last verified
- Jan 2021
- First submitted
- 2 May 2017
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03140696
- Acronym / sponsor ID
- PR-16094
- Conditions
- Protein Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 4 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Chicken egg alone | Experimental | Dietary Supplement: Egg AloneA chicken egg alone will be offered for 2 days by mouth for once a day |
| Egg and RUSF | Experimental | 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 by mouth for once a day |
| Egg and breast milk | Experimental | Dietary Supplement: Egg and breast milkA chicken egg and Mother's breast milk will be offered for 2 days by mouth for once a day |
Who may qualify
- Ages
- 6 to 8 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Children whose parents/caregivers refuse to provide informed consent will not be enrolled
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Egg AloneA chicken egg will be offered for 2 days | Dietary supplement | Chicken egg alone |
| Egg and ready to use supplementary food (RUSF)A chicken egg and ready to use supplementary food (RUSF) will be offered for 2 days | Dietary supplement | Egg and RUSF |
| Egg and breast milkA chicken egg and breast milk will be offered for 2 days | Dietary supplement | Egg and breast milk |
Primary outcome
Ideal mode of feeding egg to young infants 6-8 months of age
Time frame: 2 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muttaquina Hossain, MPH principal investigator
Research Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Egg Alone, Egg and ready to use supplementary food (RUSF) and Egg and breast milk in people with Protein Malnutrition, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ideal mode of feeding egg to young infants 6-8 months of age (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021.