Clinical trial NCT06251427: Assessing the Effectiveness of a Multiple-micronutrient Fortified Maize Pap on the Nutrient Status of Nigerian School-aged Children
Official title: Assessing the Effectiveness of a Multiple-micronutrient Fortified Maize Pap on the Nutrient Status of Nigerian School-aged Children: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Nutrient Deficiency
Iron Deficiencies
Keywords: Multiple-micronutrient fortification
School-aged children
School feeding program
Nigeria
Lead sponsor: FrieslandCampina
Sponsor class: INDUSTRY
Collaborators: name: University of Ibadan
First posted: 2024-02-09
Enrollment: 951
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three armed double blinded intervention.

1. Low dose of multiple micronutrient fortification
2. Moderate dose of multiple micronutrient fortification
3. High dose of multiple micronutrient fortification
Primary purpose: PREVENTION

Brief 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.

Detailed description: The study is a double-blinded three-arm intervention trial. The individual children will be randomised into the three different arms of the study, with varying doses of micronutrients (1) low, (2) medium and (3) high.

The 50g of study product will be given to school children every school day (5/7 days of the week) for 5 intervention months.

Study product: A fermented maize pap, with soy, dairy and multiple micronutrient fortification. Active components: Multiple micronutrient fortification, including ferrous fumarate. Amount of micronutrients differ based on the arm of the study.

Eligibility criteria: Inclusion Criteria:

1. Nigerian children in primary schools, aged 5-8 years
2. Willing and able to consume the supplied servings of the study product/s or provided control pap
3. Having written and oral informed consent from the parent/legal guardian and the participants gave oral and/or written assent.

Exclusion Criteria:

1. Children suffering from severe malnutrition and/or micronutrient deficiencies defined as (such children will be referred to a nearby health centre for appropriate treatment).

   1. Children with Height-for-age (HAZ) and Weight-for-age (WAZ) \<- 3 Standard Deviation (SD)
   2. Children showing clinical signs of severe (chronic) anemia i.e. visibly pale, jaundice and lethargic.
2. 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.
3. Children with a physical disability or handicap that prevents participation in the study.
4. Children with food allergies or intolerances.
5. Children participating in any other clinical research (or having participated in any such study in the previous half year).
6. Children or a child's family who are intending to withdraw from school or move out of the study region within the study period.
7. Children consuming prescribed 'iron/folic acid, and (multi-)vitamin, and mineral supplements' during the course of the study within the last 2 months prior to the study as a minimum.

Primary outcomes:
measure: Iron status
timeFrame: 5 months
measure: Serum ferritin
timeFrame: 5 months
Secondary outcomes:
measure: Iron deficiency, iron deficiency anaemia and anemia
timeFrame: 5 months
measure: Nutrient status
timeFrame: 5 months
Other outcomes:
measure: Cognitive performance
timeFrame: 5 months
measure: Anthropometric scores
timeFrame: 5 months
measure: Illness
timeFrame: 5 months
Locations:
city: Wageningen
country: Netherlands
facility: FrieslandCampina Research and Development
Study officials:
References: