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

Universite du Sine Saloum Elhadj Ibrahima Niasse

Status: Completed

Conditions: This Study Aimed to Evaluate the Impact of Fortified Biscuit Consumption on the Iron Status of School-aged Children in Rural Kaolack

Treatments: Dietary Supplement: Fortified Biscuit with Local Iron-Rich Ingredients; Dietary Supplement: Non-Fortified Biscuit

Study type: Interventional

Funder types: Other

Identifiers

NCT07041866

USSEIN2024

Details and patient eligibility

About

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

Enrollment: 570 patients

Sex: All

Ages: 6 to 16 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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570 participants in 2 patient groups, including a placebo group

Experimental group

Experimental group

Description:

This group included 286 school-aged children (6-16 years) enrolled in a French public elementary school in Keur Socé.

Treatment:

Dietary Supplement: Fortified Biscuit with Local Iron-Rich Ingredients

Control group

Placebo Comparator group

Description:

This group consisted of 210 children (aged 6-16 years) from a Franco-Arabic elementary school in the same locality.

Treatment:

Dietary Supplement: Non-Fortified Biscuit