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

Launched by FRIESLANDCAMPINA · Feb 8, 2024

Keywords

ClinConnect Summary

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.

Gender

ALL

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.