Vitamin A DeficiencyNigerMPSNCT05893901
Impact of Food-to-Food Fortified Cereal Products on Diet Quality in Rural Niger Villages
An observational study of Vitamin A Deficiency and Iron-deficiency, run by Purdue University at 1 site in Niger.
Trial summary
The primary hypothesis is that introduction of food-to-food fortified products through a rural Hub-and-Spoke incubator system contributes to an improved food environment and availability of micronutrients to these communities. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitamin A Deficiency, Iron-deficiency
- How many people
- 3,600 participants
- Where
- 1 siteNiger
- Study dates
- 13 Mar 2023to 30 Jun 2023
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study collected data about dietary habits for children and the household they lived. Adult caregivers were approached and provided the relevant information.
Who may be able to join
- Adults (>18 years of age), with child(ren) 5 years of age living in the household.
Who cannot join
- No children under 5 y of age living in the household.
- Not a caregiver for the children in the household.
Trial locations and contacts
1 site in 1 country.
About this study
The primary hypothesis is that introduction of food-to-food fortified products through a rural Hub-and-Spoke incubator system contributes to an improved food environment and availability of micronutrients to these communities. A secondary hypothesis is that the influence of the rural Spokes can serve to enhance rural food environments through creation of secondary rural spokes that disseminate improved food-to-food fortified products.
The overall hypothesis is that a product designed with optimized nutritional characteristics, based on consumer preferences and leveraging local nutrient dense ingredients, can successfully deliver nutrition through sustainable market-driven approaches.
Read the detailed description
Study Summary: Over the years our group has developed a Hub-and-Spoke incubator system to facilitate technology transfer and enable production, marketing, and sales of nutritionally improved cereal products in rural Niger. These efforts have led to the introduction of products developed using food-to-food fortification technology (FtFF). Examples of this include addition of moringa, carrot, cowpea, baobab powders to flours made with indigenous whole grains such as millet or sorghum. This technology leverages local nutrient dense plants to fortify cereal product traditionally consumed as porridges. These products are closely aligned to Corn-Soy Blends that are provided by international aid groups and dispensed/distributed through health centers at the village level. While these products provide a more complete nutritional profile for growing children and their families, their acceptability by children not always good and sustainability is poor as they are donor supported. Efforts to enhance the local community's food security and enhance nutritional quality of diets through local production and sales of FtFF products is key to developing sustainable improvements in local diets and nutrient availability. The investigators believe that the presence of Hub and Spoke incubator is critical to the success of these efforts, but data is needed to confirm their impact on the local food environment.
Study procedures:
Participants will be approached/recruited by research assistants (enumerators) in local markets and at sales locations. Potential participants will be approached and consented if they agree to join the study at the time of recruitment. Research assistants will read the consent form to the participants and ensure they understand it.
During the consumer interview, the investigators will be collecting the following information:
Consumer socioeconomics (for all) - this includes sex and age of each family member (no names or birth dates), and education level of the respondent Modified Food Frequency Questionnaire (for all) Diet Diversity Questionnaire - focus on pearl millet consumption (for all) Product specific questionnaire (for purchasers only)
- Product use: time of day, people in the household
- Product attributes they found most attractive
- 5-point-like scale: appearance, aroma, texture, taste.
- Overall convenience of flour product
- If small children were fed product, did they like it?
- Did other children like it?
- What did it replace?
- Conditions
- Vitamin A Deficiency, Iron-deficiency
- Medical subject headings
- Vitamin A Deficiency, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Consumers of cereal products | Caregivers with children under 5 years of age who are consumer of cereal products in the Maradi, Falwell and Tera areas in Niger. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of staple intake in urban Nigerien households and children
A quantitative, modified food frequency questionnaire (FFQ) will be used to assess consumption of starch rich staples (rice, wheat, corn sorghum, millet, fonio, potatoes, cassava, yams) for the whole household and children. This will be measured in g/day*child. The investigators will ask #times/week eachstaple was consumed as well as the average portion size consumed each time (g).The caregiver will provide information about the child's frequency of consumption over the past week for each food group.
Measured: 3 months
Assessment of the nutritional adequacy of Nigerien children
Nutritional status of children in the household will be assessed using theFood Consumption Score Nutritional Quality Analysis (FCS-N) which wasbased on country-specific food groups. Food groups are orange fruits,orange vegetables, other fruits, eggs, dairy, organ meats, meat, fish,grains and legumes. Example of food items in the FCS-N assessment will be corroborated by a Nigerien maternal and child health expert. This will be measured in #times/week each food group was consumed.
Measured: 3 years
Nutritional impact of a fortified cereal-based product for the improvement of micronutrient deficiencies among children aged 24-60 months.
Fortified flour consumption will be assessed by fortified flours intake(g/child*day). Micronutrient contribution will calculated by multiplying the amount of flour consumed/child * (mg zinc/g flour), (mg iron/g flour) and(ug RAE vitamin A/g flour).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start13 Mar 2023
- Primary completion30 May 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin A DeficiencyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 3,600 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce R. Hamaker, Purdue University
- Investigators
- Bruce R Hamaker, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893901
- Sponsor's protocol ID
- IRB-2022-571
- Acronym
- NigerMPS
- Status last verified
- Jul 2023
- First submitted
- 30 May 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No personal information was collected. There is not a plan to share data collected.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Food-to-Food Fortified Cereal Products on Diet Quality in Rural Niger Villages
- ClinicalTrials.gov ID
- NCT05893901
- Acronym / sponsor ID
- NigerMPS / IRB-2022-571
- Conditions
- Vitamin A Deficiency, Iron-deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,600 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 8 Jun 2023 (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.
The primary hypothesis is that introduction of food-to-food fortified products through a rural Hub-and-Spoke incubator system contributes to an improved food environment and availability of micronutrients to these communities. A secondary hypothesis is that the influence of the rural Spokes can serve to enhance rural food environments through creation of secondary rural spokes that disseminate improved food-to-food fortified products.
The overall hypothesis is that a product designed with optimized nutritional characteristics, based on consumer preferences and leveraging local nutrient dense ingredients, can successfully deliver nutrition through sustainable market-driven approaches.
Detailed description
Study Summary: Over the years our group has developed a Hub-and-Spoke incubator system to facilitate technology transfer and enable production, marketing, and sales of nutritionally improved cereal products in rural Niger. These efforts have led to the introduction of products developed using food-to-food fortification technology (FtFF). Examples of this include addition of moringa, carrot, cowpea, baobab powders to flours made with indigenous whole grains such as millet or sorghum. This technology leverages local nutrient dense plants to fortify cereal product traditionally consumed as porridges. These products are closely aligned to Corn-Soy Blends that are provided by international aid groups and dispensed/distributed through health centers at the village level. While these products provide a more complete nutritional profile for growing children and their families, their acceptability by children not always good and sustainability is poor as they are donor supported. Efforts to enhance the local community's food security and enhance nutritional quality of diets through local production and sales of FtFF products is key to developing sustainable improvements in local diets and nutrient availability. The investigators believe that the presence of Hub and Spoke incubator is critical to the success of these efforts, but data is needed to confirm their impact on the local food environment.
Study procedures:
Participants will be approached/recruited by research assistants (enumerators) in local markets and at sales locations. Potential participants will be approached and consented if they agree to join the study at the time of recruitment. Research assistants will read the consent form to the participants and ensure they understand it.
During the consumer interview, the investigators will be collecting the following information:
Consumer socioeconomics (for all) - this includes sex and age of each family member (no names or birth dates), and education level of the respondent Modified Food Frequency Questionnaire (for all) Diet Diversity Questionnaire - focus on pearl millet consumption (for all) Product specific questionnaire (for purchasers only)
- Product use: time of day, people in the household
- Product attributes they found most attractive
- 5-point-like scale: appearance, aroma, texture, taste.
- Overall convenience of flour product
- If small children were fed product, did they like it?
- Did other children like it?
- What did it replace?
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Consumers of cereal products | – | –Caregivers with children under 5 years of age who are consumer of cereal products in the Maradi, Falwell and Tera areas in Niger. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study collected data about dietary habits for children and the household they lived. Adult caregivers were approached and provided the relevant information.
Key inclusion criteria (1 listed)
- Adults (>18 years of age), with child(ren) 5 years of age living in the household.
Key exclusion criteria (2 listed)
- No children under 5 y of age living in the household.
- Not a caregiver for the children in the household.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of staple intake in urban Nigerien households and children
Time frame: 3 months
A quantitative, modified food frequency questionnaire (FFQ) will be used to assess consumption of starch rich staples (rice, wheat, corn sorghum, millet, fonio, potatoes, cassava, yams) for the whole household and children. This will be measured in g/day*child. The investigators will ask #times/week eachstaple was consumed as well as the average portion size consumed each time (g).The caregiver will provide information about the child's frequency of consumption over the past week for each food group.
Assessment of the nutritional adequacy of Nigerien children
Time frame: 3 years
Nutritional status of children in the household will be assessed using theFood Consumption Score Nutritional Quality Analysis (FCS-N) which wasbased on country-specific food groups. Food groups are orange fruits,orange vegetables, other fruits, eggs, dairy, organ meats, meat, fish,grains and legumes. Example of food items in the FCS-N assessment will be corroborated by a Nigerien maternal and child health expert. This will be measured in #times/week each food group was consumed.
Nutritional impact of a fortified cereal-based product for the improvement of micronutrient deficiencies among children aged 24-60 months.
Time frame: 3 months
Fortified flour consumption will be assessed by fortified flours intake(g/child*day). Micronutrient contribution will calculated by multiplying the amount of flour consumed/child * (mg zinc/g flour), (mg iron/g flour) and(ug RAE vitamin A/g flour).
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 11 Jul 2023.
- Individual participant dataSharing planned: No. No personal information was collected. There is not a plan to share data collected.
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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.
Bruce R Hamaker, PhD principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin A Deficiency and Iron-deficiency, run by Purdue University at 1 site in Niger.
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 2 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 11 Jul 2023. 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 Niger. 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?
Assessment of staple intake in urban Nigerien households and children (time frame: 3 months). The study lists 3 primary outcomes in all. 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 11 Jul 2023.