This Study Aimed to Evaluate the Impact of Fortified Biscuit Consumption on the Iron Status of School-aged Children in Rural Kaolack
Conditions
Keywords
Fortified biscuit, school-aged children, iron status, anemia, nutritional status, Senegal.
Brief 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 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
Interventions
DIETARY_SUPPLEMENTFortified Biscuit with Local Iron-Rich Ingredients
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.
DIETARY_SUPPLEMENTNon-Fortified Biscuit
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.
Sponsors
Universite du Sine Saloum Elhadj Ibrahima Niasse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
In this study, both participants and data collectors were blinded to the group assignments. Participants were unaware whether they were receiving the iron-fortified biscuit or the placebo biscuit, as both were similar in appearance and taste. Additionally, data collectors responsible for anthropometric and biological measurements were not informed of the participants' allocation to ensure objectivity in data collection. However, the study coordinators and investigators were aware of the intervention allocation due to the nature of the study design.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence of iron deficiency | At baseline and at 3 months (endline) |
| Change in serum ferritin concentration (ng/mL) | At baseline and at 3 months (endline) |
Secondary
| Measure | Time frame |
|---|---|
| Prevalence of anemia (mild, moderate, severe) | At baseline and at 3 months (endline |
| Change in BMI-for-age Z-score (BMIZ-WHO) | At baseline and at 3 months (endline |
| C-reactive protein (CRP) concentration | At baseline and at 3 months (endline) |
| Alpha-1-acid glycoprotein (AGP) concentration | At baseline and at 3 months (endline) |
| prevalence of thinness (BMIZ < -2 SD) | At baseline and at 3 months (endline) |
| Change in hemoglobin concentration (g/dL) | At baseline and at 3 months (endline) |
Other
| Measure | Time frame |
|---|---|
| Sex (male/female) | at baseline |
| Age of participants | At baseline and at 3 months (endline) |
Countries
Senegal
Outcome results
None listed