An interventional study of Fortified Biscuit with Local Iron-Rich Ingredients and Non-Fortified Biscuit in This Study Aimed to Evaluate the Impact of Fortified Biscuit Consumption on the Iron Status of School-aged Children in Rural Kaolack, sponsored by Universite du Sine Saloum Elhadj Ibrahima Niasse. Completed at 1 site in Senegal. Open to participants aged 6 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-27.
Sponsored by Universite du Sine Saloum Elhadj Ibrahima Niasse · Not applicable, Interventional, and Treatment
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:
Participants:
1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.
This study's enrollment of 570 is above the median of 117 across 1,336 interventional studies indexed under Anemia.
Browse Anemia studies →This is the only study on the registry with Universite du Sine Saloum Elhadj Ibrahima Niasse as lead sponsor.
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group included 286 school-aged children (6-16 years) enrolled in a French public elementary school in Keur Socé.
Dietary Supplement: Fortified Biscuit with Local Iron-Rich Ingredients
This group consisted of 210 children (aged 6-16 years) from a Franco-Arabic elementary school in the same locality.
Dietary Supplement: Non-Fortified Biscuit
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.
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.
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)
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)
Sex (male/female)
Time frame: at baseline
Age of participants
Time frame: At baseline and at 3 months (endline)
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Feb 2024 to primary completion in Jun 2024, 3 months.
Of 163 non-industry interventional studies with no phase under Anemia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 30. This study's 3 months is below that.
Counting every sponsor, half of 177 studies reached it within 17 months; a quarter within 7 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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