An observational study in Vitamin A Deficiency and Iron-deficiency, sponsored by Purdue University. Completed at 1 site in Niger. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-11.
Sponsored by Purdue University · Observational
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.
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)
67 studies on the registry are indexed under Vitamin A Deficiency; 7 are open to participants now.
This study's enrollment of 3,600 is above the median of 258 across 17 observational studies indexed under Vitamin A Deficiency.
Browse Vitamin A Deficiency studies →Purdue University is the lead sponsor of 175 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This study collected data about dietary habits for children and the household they lived. Adult caregivers were approached and provided the relevant information.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Caregivers with children under 5 years of age who are consumer of cereal products in the Maradi, Falwell and Tera areas in Niger.
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.
Time frame: 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.
Time frame: 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).
Time frame: 3 months
Plan to share: No — No personal information was collected. There is not a plan to share data collected.
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.