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Completed

NCT Number: NCT07041866

Impact of the Consumption of Fortified Biscuits on the Iron Status of School-aged Children

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

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Key information

Conditions

This Study Aimed to Evaluate the Impact of Fortified Biscuit Consumption on the Iron Status of School-aged Children in Rural Kaolack Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

École Élémentaire de Keur Socé City: Kaolack Country: Senegal

Kaolack, Senegal

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fortified Biscuit with Local Iron-Rich Ingredients

Dietary 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 Biscuit

Dietary 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.

Primary outcomes

  1. Change in serum ferritin concentration (ng/mL)

    Time frame: At baseline and at 3 months (endline)

  2. Prevalence of iron deficiency

    Time frame: At baseline and at 3 months (endline)

Secondary outcomes

  1. Change in hemoglobin concentration (g/dL)

    Time frame: At baseline and at 3 months (endline)

  2. Prevalence of anemia (mild, moderate, severe)

    Time frame: At baseline and at 3 months (endline

  3. Change in BMI-for-age Z-score (BMIZ-WHO)

    Time frame: At baseline and at 3 months (endline

  4. prevalence of thinness (BMIZ < -2 SD)

    Time frame: At baseline and at 3 months (endline)

  5. C-reactive protein (CRP) concentration

    Time frame: At baseline and at 3 months (endline)

  6. Alpha-1-acid glycoprotein (AGP) concentration

    Time frame: At baseline and at 3 months (endline)

Other outcomes

  1. Sex (male/female)

    Time frame: at baseline

  2. Age of participants

    Time frame: At baseline and at 3 months (endline)

Sponsors and collaborators

Lead sponsor

Universite du Sine Saloum Elhadj Ibrahima Niasse

Other

Registry information

Official study title

Impact of the Consumption of Fortified Biscuits on the Iron Status of School-aged Children in a Rural Setting in Kaolack, Central Senegal

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 27, 2025
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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