This Study Aimed to Evaluate the Impact of Fortified Biscuit Consumption on the Iron Status of School-aged Children in Rural KaolackNCT07041866
Impact of the Consumption of Fortified Biscuits on the Iron Status of School-aged Children
A study testing Fortified Biscuit with Local Iron-Rich Ingredients and Non-Fortified Biscuit in people with This Study Aimed to Evaluate the Impact of Fortified Biscuit Consumption on the Iron Status of School-aged Children in Rural Kaolack, run by Universite du Sine Saloum Elhadj Ibrahima Niasse at 1 site in Senegal.
Trial summary
This study aimed to evaluate the impact of fortified biscuit consumption on the iron status of school-aged children in rural Kaolack. The main question it aims to answer is: Does the consumption of iron-fortified biscuits improve the iron status of school-aged children? Researchers compared the iron-fortified biscuit… Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- This Study Aimed to Evaluate the Impact of Fortified Biscuit Consumption on the Iron Status of School-aged Children in Rural Kaolack
- What is being tested?
- Fortified Biscuit with Local Iron-Rich Ingredients and Non-Fortified Biscuit
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 570 participants
- Where
- 1 siteSenegal
- Study dates
- 15 Feb 2024to 15 Jun 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 6 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6 to 16 years
- Enrolled in one of the two selected elementary schools (French or Franco-Arab)
- Availability to participate throughout the 3-month intervention period
- Obtained written informed consent from parent or guardian Verbal assent obtained from the child
Who cannot join
- Children diagnosed with sickle cell disease (SCD)
- Children currently under iron supplementation or treatment at the start of the study
- Refusal to participate or withdrawal of consent at any time
Trial locations and contacts
1 site in 1 country.
Senegal1 site
École Élémentaire de Keur Socé City: Kaolack Country: Senegal
Kaolack
About this study
Official title: Impact of the Consumption of Fortified Biscuits on the Iron Status of School-aged Children in a Rural Setting in Kaolack, Central Senegal
This study aimed to evaluate the impact of fortified biscuit consumption on the iron status of school-aged children in rural Kaolack.
The main question it aims to answer is:
- Does the consumption of iron-fortified biscuits improve the iron status of school-aged children? Researchers compared the iron-fortified biscuit to a placebo (a biscuit similar in appearance but without iron-rich ingredients) to measure its effectiveness.
Participants:
- Consumed either the fortified biscuit or the placebo daily for 3 months
- Took part in data collection after 3 months of biscuit consumption
- Being tested
- Fortified Biscuit with Local Iron-Rich Ingredients, Non-Fortified Biscuit
- Keywords
- Fortified biscuit, school-aged children, iron status, anemia, nutritional status, Senegal.
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fortified Biscuit with Local Iron-Rich IngredientsDietary supplement
Participants consumed one fortified biscuit per day, five days a week (school days), for a period of three months. The biscuit was formulated using wheat flour, millet, maize, peanut paste, sugar, and was filled with a blend of Moringa oleifera, Hibiscus sabdariffa, Adansonia digitata, and Detarium senegalense-all selected for their high iron and vitamin C content. The iron content was approximately 4 mg per 100 g.
Non-Fortified BiscuitDietary supplement
Participants received a placebo biscuit daily for the same period and frequency as the intervention group. The placebo biscuit was visually and texturally identical to the fortified biscuit but did not contain the micronutrient-rich filling.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | This group included 286 school-aged children (6-16 years) enrolled in a French public elementary school in Keur Socé. Receives: Dietary Supplement: Fortified Biscuit with Local Iron-Rich Ingredients |
| Control group | Placebo comparator | This group consisted of 210 children (aged 6-16 years) from a Franco-Arabic elementary school in the same locality. Receives: Dietary Supplement: Non-Fortified Biscuit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum ferritin concentration (ng/mL)
Measured: At baseline and at 3 months (endline)
Prevalence of iron deficiency
Measured: At baseline and at 3 months (endline)
Secondary outcomes (6)
Change in hemoglobin concentration (g/dL)
Measured: At baseline and at 3 months (endline)
Prevalence of anemia (mild, moderate, severe)
Measured: At baseline and at 3 months (endline
Change in BMI-for-age Z-score (BMIZ-WHO)
Measured: At baseline and at 3 months (endline
prevalence of thinness (BMIZ < -2 SD)
Measured: At baseline and at 3 months (endline)
C-reactive protein (CRP) concentration
Measured: At baseline and at 3 months (endline)
Alpha-1-acid glycoprotein (AGP) concentration
Measured: At baseline and at 3 months (endline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start15 Feb 2024
- Primary completion10 Jun 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for This Study Aimed to Evaluate the Impact of Fortified Biscuit Consumption on the Iron Status of School-aged Children in Rural KaolackStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to one of two parallel groups: an intervention group receiving iron-fortified biscuits and a control group receiving placebo biscuits with similar appearance but without iron-rich ingredients. The intervention lasted for 3 months, and outcomes were assessed before and after the intervention period.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 570 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universite du Sine Saloum Elhadj Ibrahima Niasse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041866
- Sponsor's protocol ID
- USSEIN2024
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Consumption of Fortified Biscuits on the Iron Status of School-aged Children in a Rural Setting in Kaolack, Central Senegal
- ClinicalTrials.gov ID
- NCT07041866
- Acronym / sponsor ID
- USSEIN2024
- Keywords
- Fortified biscuit, school-aged children, iron status, anemia, nutritional status, Senegal.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 570 participants (actual)
- Lead sponsor
- Universite du Sine Saloum Elhadj Ibrahima NiasseUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 27 Jun 2025 (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.
This study aimed to evaluate the impact of fortified biscuit consumption on the iron status of school-aged children in rural Kaolack.
The main question it aims to answer is:
- Does the consumption of iron-fortified biscuits improve the iron status of school-aged children? Researchers compared the iron-fortified biscuit to a placebo (a biscuit similar in appearance but without iron-rich ingredients) to measure its effectiveness.
Participants:
- Consumed either the fortified biscuit or the placebo daily for 3 months
- Took part in data collection after 3 months of biscuit consumption
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to one of two parallel groups: an intervention group receiving iron-fortified biscuits and a control group receiving placebo biscuits with similar appearance but without iron-rich ingredients. The intervention lasted for 3 months, and outcomes were assessed before and after the intervention period.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Dietary Supplement: Fortified Biscuit with Local Iron-Rich IngredientsThis group included 286 school-aged children (6-16 years) enrolled in a French public elementary school in Keur Socé. |
| Control group | Placebo comparator | Dietary Supplement: Non-Fortified BiscuitThis group consisted of 210 children (aged 6-16 years) from a Franco-Arabic elementary school in the same locality. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 6 to 16 years
- Enrolled in one of the two selected elementary schools (French or Franco-Arab)
- Availability to participate throughout the 3-month intervention period
- Obtained written informed consent from parent or guardian Verbal assent obtained from the child
Key exclusion criteria (3 listed)
- Children diagnosed with sickle cell disease (SCD)
- Children currently under iron supplementation or treatment at the start of the study
- Refusal to participate or withdrawal of consent at any time
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 |
|---|---|---|
| Fortified Biscuit with Local Iron-Rich IngredientsParticipants consumed one fortified biscuit per day, five days a week (school days), for a period of three months. The biscuit was formulated using wheat flour, millet, maize, peanut paste, sugar, and was filled with a blend of Moringa oleifera, Hibiscus sabdariffa, Adansonia digitata, and Detarium senegalense-all selected for their high iron and vitamin C content. The iron content was approximately 4 mg per 100 g. | Dietary supplement | Experimental group |
| Non-Fortified BiscuitParticipants received a placebo biscuit daily for the same period and frequency as the intervention group. The placebo biscuit was visually and texturally identical to the fortified biscuit but did not contain the micronutrient-rich filling. | Dietary supplement | Control group |
Primary outcome
Change in serum ferritin concentration (ng/mL)
Time frame: At baseline and at 3 months (endline)
Prevalence of iron deficiency
Time frame: At baseline and at 3 months (endline)
6 secondary outcomes
Change in hemoglobin concentration (g/dL)
Time frame: At baseline and at 3 months (endline)
Prevalence of anemia (mild, moderate, severe)
Time frame: At baseline and at 3 months (endline
Change in BMI-for-age Z-score (BMIZ-WHO)
Time frame: At baseline and at 3 months (endline
prevalence of thinness (BMIZ < -2 SD)
Time frame: At baseline and at 3 months (endline)
C-reactive protein (CRP) concentration
Time frame: At baseline and at 3 months (endline)
Alpha-1-acid glycoprotein (AGP) concentration
Time frame: At baseline and at 3 months (endline)
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 27 Jun 2025.
- Individual participant dataSharing planned: Undecided
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 Fortified Biscuit with Local Iron-Rich Ingredients and Non-Fortified Biscuit in people with This Study Aimed to Evaluate the Impact of Fortified Biscuit Consumption on the Iron Status of School-aged Children in Rural Kaolack, run by Universite du Sine Saloum Elhadj Ibrahima Niasse at 1 site in Senegal.
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 4 inclusion and 3 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 27 Jun 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 Senegal. 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?
Change in serum ferritin concentration (ng/mL) (time frame: At baseline and at 3 months (endline)). 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 27 Jun 2025.