Assessing the Effectiveness of a Multiple-micronutrient Fortified Maize Pap on the Nutrient Statu… (NCT06251427) | Clinical Trial Compass
CompletedNot Applicable
Assessing the Effectiveness of a Multiple-micronutrient Fortified Maize Pap on the Nutrient Status of Nigerian School-aged Children
Netherlands934 participantsStarted 2024-01-24
Plain-language summary
A new product was developed by FrieslandCampina for Sub-Saharan Africa as affordable nutrition to nourish Nigerian families of low to middle-socioeconomic class (SEC). It can potentially be used to enhance the ongoing school feeding programs, which are aimed at reducing malnutrition, including micronutrient deficiencies. The main component of the product is maize, which is a traditional staple in Nigeria. The product also contains milk (being a good source of high quality protein) fortified with various micronutrients including iron, iodine, zinc, vitamin A and vitamin B12 at levels contributing to approximately 1/3 of daily recommended intakes per serving of product. Intake of this product may therefore contribute to improvement of micronutrient status among Nigerian schoolchildren suffering from such nutrient deficiencies. Micronutrients are important for various processes in the body, which in turn may influence other outcomes as cognitive performance, reduce illness and improve growth.
Who can participate
Age range
5 Years – 8 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Nigerian children in primary schools, aged 5-8 years
. Willing and able to consume the supplied servings of the study product/s or provided control pap
. Having written and oral informed consent from the parent/legal guardian and the participants gave oral and/or written assent.
Exclusion criteria
. Children suffering from severe malnutrition and/or micronutrient deficiencies defined as (such children will be referred to a nearby health centre for appropriate treatment).
. Children with Height-for-age (HAZ) and Weight-for-age (WAZ) \<- 3 Standard Deviation (SD)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Children showing clinical signs of severe (chronic) anemia i.e. visibly pale, jaundice and lethargic.
. Children with a history of or who at the time of recruitment suffer from chronic illness, including (but not limited to) renal diseases, thyroid disease, (metabolic) bone disease, genetic and/or congenital disorders e.g. Down syndrome and sickle cell anaemia, hepatic dysfunction, thalassemia or chronic diarrhea (e.g. irritable bowl syndrome). Based on medical history examination.
. Children with a physical disability or handicap that prevents participation in the study.
. Children with food allergies or intolerances.
. Children participating in any other clinical research (or having participated in any such study in the previous half year).
. Children or a child's family who are intending to withdraw from school or move out of the study region within the study period.