An interventional study of Multiple micronutrient fortified maize with milk in Iron Deficiencies, sponsored by FrieslandCampina. Completed at 1 site in Netherlands. Open to participants aged 5 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-28.
Sponsored by FrieslandCampina · Not applicable, Interventional, and Prevention
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.
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.
772 studies on the registry are indexed under Iron Deficiencies; 115 are open to participants now.
This study's enrollment of 934 is above the median of 100 across 592 interventional studies indexed under Iron Deficiencies.
Browse Iron Deficiencies studies →FrieslandCampina is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
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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).
Maize, milk plus low multiple micronutrient fortification
Dietary Supplement: Multiple micronutrient fortified maize with milk
Maize, milk plus moderate multiple micronutrient fortification
Dietary Supplement: Multiple micronutrient fortified maize with milk
Maize, milk plus high multiple micronutrient fortification (double the moderate level)
Dietary Supplement: Multiple micronutrient fortified maize with milk
The study product is a multiple micronutrient fortified maize pap with milk
Iron status
There will be a change between the two test groups and the control group in iron status as measured by in hemoglobin (whole blood) g/L .
Time frame: 5 months
Serum ferritin
There will be a change between the two test groups and the control group in iron status as measured by serum ferritin (ug/L).
Time frame: 5 months
Iron deficiency, iron deficiency anaemia and anemia
There will be a difference in prevalence of iron-deficiency, iron-deficiency anaemia and anaemia, taking modifying factors like soluble transferrin receptor and inflammation markers in plasma into account.
Time frame: 5 months
Nutrient status
A difference in nutrient status of selected nutrients (iodine, vitamin A, zinc, vitamin B12, vitamin D)
Time frame: 5 months
Cognitive performance
A difference in cognitive performance score, measured via attention (Digit span backward) and short-term memory (digit-span forward) score (higher scores indicate a better outcome.
Time frame: 5 months
Anthropometric scores
Difference in anthropometric status between study arms as measured by height-for-age Z score (HAZ) and weight-for-age (WAZ).
Time frame: 5 months
Illness
Difference in morbidity/illness as measured by the reduced frequency of illness over the 5 months
Time frame: 5 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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FrieslandCampina