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

Nutrient Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06251427
• Other study ID #: Aladdin
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 6, 2024
• Est. completion date: August 13, 2024

Study information

• Verified date: February 2024
• Source: FrieslandCampina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 951
• Est. completion date: August 13, 2024
• Est. primary completion date: August 13, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nutrient Deficiency

Intervention

Dietary Supplement:
• Multiple micronutrient fortified maize with milk
The study product is a multiple micronutrient fortified maize pap with milk

Locations

Country	Name	City	State
Netherlands	FrieslandCampina Research and Development	Wageningen

Sponsors (2)

Lead Sponsor	Collaborator
FrieslandCampina	University of Ibadan

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Illness	Difference in morbidity/illness as measured by the reduced frequency of illness over the 5 months	5 months
Primary	Iron status	There will be a change between the two test groups and the control group and between the two test groups in iron status as measured by in hemoglobin (whole blood) g/L.	5 months
Primary	Serum ferritin	There will be a change between the two test groups and the control group and between the two test groups in iron status as measured by serum ferritin (ug/L).	5 months
Secondary	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
Secondary	Nutrient status	A difference in nutrient status of selected nutrients (iodine, vitamin A, zinc, vitamin B12, vitamin D)	5 months