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

NCT06251427 | Completed DMC

• 1 other identifier: Aladdin
• Study Type: interventional
• Target: 934
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Deficiencies

Keywords

School-aged children; Nigeria; Multiple-micronutrient fortification; School feeding program

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Iron deficiency, iron deficiency anaemia and anemia

  5 months

• Nutrient status

  5 months

Other Outcomes (3)

• Cognitive performance

  5 months

• Anthropometric scores

  5 months

• Illness

  5 months

Study Arms (3)

Low dose multiple micronutrient fortification

PLACEBO COMPARATOR

Maize, milk plus low multiple micronutrient fortification

Dietary Supplement: Multiple micronutrient fortified maize with milk

Moderate dose multiple micronutrient fortification

ACTIVE COMPARATOR

Maize, milk plus moderate multiple micronutrient fortification

Dietary Supplement: Multiple micronutrient fortified maize with milk

High dose multiple micronutrient fortification

ACTIVE COMPARATOR

Maize, milk plus high multiple micronutrient fortification (double the moderate level)

Dietary Supplement: Multiple micronutrient fortified maize with milk

Interventions

Multiple micronutrient fortified maize with milk DIETARY_SUPPLEMENT

The study product is a multiple micronutrient fortified maize pap with milk

High dose multiple micronutrient fortification; Low dose multiple micronutrient fortification; Moderate dose multiple micronutrient fortification

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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.
• 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.

Sponsors & Collaborators

• FrieslandCampina: lead
• University of Ibadan: collaborator

Study Sites (1)

FrieslandCampina Research and Development

Wageningen, 6708 WH, Netherlands

Location

MeSH Terms

Conditions

Iron Deficiencies

Interventions

Milk

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: February 9, 2024
• Study Start: January 24, 2024
• Primary Completion: August 2, 2024
• Study Completion: August 2, 2024
• Last Updated: July 28, 2025

Record last verified: 2025-07

Locations

NL (1)