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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

570 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-15

Study Completion Date

2024-06-15

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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Experimental group

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

Group Type EXPERIMENTAL

Fortified Biscuit with Local Iron-Rich Ingredients

Intervention Type 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.

Control group

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

Group Type PLACEBO_COMPARATOR

Non-Fortified Biscuit

Intervention Type 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.

Interventions

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Fortified 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.

Intervention Type DIETARY_SUPPLEMENT

Non-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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes