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

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.

Study Overview

• Status: Completed
• Conditions: Iron Deficiencies
• Intervention / Treatment: Dietary supplement: Multiple micronutrient fortified maize with milk

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.

• Study Type: Interventional
• Enrollment (Actual): 934
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Wageningen, Netherlands, 6708 WH
    • FrieslandCampina Research and Development

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Low dose multiple micronutrient fortification; Maize, milk plus low multiple micronutrient fortification	Dietary supplement: Multiple micronutrient fortified maize with milk; The study product is a multiple micronutrient fortified maize pap with milk
Active Comparator: Moderate dose multiple micronutrient fortification; Maize, milk plus moderate multiple micronutrient fortification	Dietary supplement: Multiple micronutrient fortified maize with milk; The study product is a multiple micronutrient fortified maize pap with milk
Active Comparator: High dose multiple micronutrient fortification; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 .	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).	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 months
Nutrient status	A difference in nutrient status of selected nutrients (iodine, vitamin A, zinc, vitamin B12, vitamin D)	5 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	5 months
Illness	Difference in morbidity/illness as measured by the reduced frequency of illness over the 5 months	5 months

Collaborators and Investigators

• Sponsor: FrieslandCampina
• Collaborators: University of Ibadan

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2024
• Primary Completion (Actual): August 2, 2024
• Study Completion (Actual): August 2, 2024

Study Registration Dates

• First Submitted: January 17, 2024
• First Submitted That Met QC Criteria: February 8, 2024
• First Posted (Actual): February 9, 2024

Study Record Updates

• Last Update Posted (Actual): July 28, 2025
• Last Update Submitted That Met QC Criteria: July 23, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Nigeria; School-aged children; Multiple-micronutrient fortification; School feeding program
• Additional Relevant MeSH Terms: Metabolic Diseases; Iron Metabolism Disorders; Iron Deficiencies; Physiological Effects of Drugs; Micronutrients; Trace Elements
• Other Study ID Numbers: Aladdin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No