Iron DeficienciesNCT06251427
Assessing the Effectiveness of a Multiple-micronutrient Fortified Maize Pap on the Nutrient Status of Nigerian School-aged Children
A study testing Multiple micronutrient fortified maize with milk in people with Iron Deficiencies, run by FrieslandCampina at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 5 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiencies
- What is being tested?
- Multiple micronutrient fortified maize with milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 934 participants
- Where
- 1 siteNetherlands
- Study dates
- 24 Jan 2024to 2 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
FrieslandCampina Research and Development
Wageningen, 6708 WH
About this study
Official title: 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.
Read the 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.
- Conditions
- Iron Deficiencies
- Being tested
- Multiple micronutrient fortified maize with milk
- Keywords
- School-aged children, Nigeria, Multiple-micronutrient fortification, School feeding program
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple micronutrient fortified maize with milkDietary supplement
The study product is a multiple micronutrient fortified maize pap with milk
| Study group | Role | What they receive |
|---|---|---|
| Low dose multiple micronutrient fortification | Placebo comparator | Maize, milk plus low multiple micronutrient fortification Receives: Dietary Supplement: Multiple micronutrient fortified maize with milk |
| Moderate dose multiple micronutrient fortification | Active comparator | Maize, milk plus moderate multiple micronutrient fortification Receives: 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) Receives: Dietary Supplement: Multiple micronutrient fortified maize with milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 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).
Measured: 5 months
Secondary outcomes (2)
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.
Measured: 5 months
Nutrient status
A difference in nutrient status of selected nutrients (iodine, vitamin A, zinc, vitamin B12, vitamin D)
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start24 Jan 2024
- Primary completion2 Aug 2024
- Study completion2 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron DeficienciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 934 participants (actual)
Sponsor and investigators
- Lead sponsor
- FrieslandCampina
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Ibadan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251427
- Sponsor's protocol ID
- Aladdin
- Status last verified
- Jul 2025
- First submitted
- 17 Jan 2024
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effectiveness of a Multiple-micronutrient Fortified Maize Pap on the Nutrient Status of Nigerian School-aged Children: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06251427
- Acronym / sponsor ID
- Aladdin
- Conditions
- Iron Deficiencies
- Keywords
- School-aged children, Nigeria, Multiple-micronutrient fortification, School feeding program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 934 participants (actual)
- Lead sponsor
- FrieslandCampinaIndustry (pharma, biotech, devices)
- Collaborators
- University of Ibadan
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 2 Aug 2024 (actual)
- Study completion
- 2 Aug 2024 (actual)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Low dose multiple micronutrient fortification | Placebo comparator | Dietary Supplement: Multiple micronutrient fortified maize with milkMaize, milk plus low multiple micronutrient fortification |
| Moderate dose multiple micronutrient fortification | Active comparator | Dietary Supplement: Multiple micronutrient fortified maize with milkMaize, milk plus moderate multiple micronutrient fortification |
| High dose multiple micronutrient fortification | Active comparator | Dietary Supplement: Multiple micronutrient fortified maize with milkMaize, milk plus high multiple micronutrient fortification (double the moderate level) |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiple micronutrient fortified maize with milkThe study product is a multiple micronutrient fortified maize pap with milk | Dietary supplement | High dose multiple micronutrient fortification, Low dose multiple micronutrient fortification, Moderate dose multiple micronutrient fortification |
Primary outcome
Iron status
Time frame: 5 months
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 .
Serum ferritin
Time frame: 5 months
There will be a change between the two test groups and the control group in iron status as measured by serum ferritin (ug/L).
2 secondary outcomes
Iron deficiency, iron deficiency anaemia and anemia
Time frame: 5 months
Nutrient status
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiple micronutrient fortified maize with milk in people with Iron Deficiencies, run by FrieslandCampina at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iron status (time frame: 5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.