NCT06251427

Assessing the Effectiveness of a Multiple-micronutrient Fortified Maize Pap on the Nutrient Status of Nigerian School-aged Children

Assessing the Effectiveness of a Multiple-micronutrient Fortified Maize Pap on the Nutrient Status of Nigerian School-aged Children: Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 934 (actual)
• Sponsor: FrieslandCampina · Industry
• Sex: All
• Age: 5 Years – 8 Years
• Healthy volunteers: Accepted

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.

Conditions

• Iron Deficiencies

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Multiple micronutrient fortified maize with milk	The study product is a multiple micronutrient fortified maize pap with milk

Timeline

• Start date: 2024-01-24
• Primary completion: 2024-08-02
• Completion: 2024-08-02
• First posted: 2024-02-09
• Last updated: 2025-07-28

Locations

1 site across 1 country: Netherlands