Iron-Rich Snack Intervention for Anemia in Adolescent Girls

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age16-18
SponsorUniversity of Veterinary and Animal Sciences, Lahore - Pakistan

About this trial

This randomized controlled trial aims to evaluate the effectiveness of iron-rich snacks in combating anemia among adolescent girls. The study will involve 100 girls aged 16-18 years with mild anemia (Hb 11-11.9 g/dL), randomly divided into an intervention group and a control group. The intervention group will consume two 25-g iron-rich bars daily for 12 weeks, while the control group will continue their regular diet. Hemoglobin and anemia status will be assessed to determine the effectiveness of the intervention. Data will be analyzed using SPSS, with p ≤ 0.05 considered statistically significant.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adolescent girls aged 16-18 years

Have mild iron deficiency anemia (Hb=11-11.9g/dl)

Enrolled in selected colleges in Lahore

Willing to participate for 3 months

Disqualifiers

Moderate and severe iron deficiency anemia requiring medical treatment

Currently taking iron supplements

Allergy to ingredients in iron rich balls

Having chronic GIT disorders

Trial design

Design model

Parallel

Treatments tested in this trial

  • Iron Rich Bars

    Dietary supplement

    The proposed iron-rich bar differs from previous interventions through its unique combination of locally available sesame seeds, roasted chickpeas, jaggery, and fenugreek, providing 2.9 mg iron per 25 g bar without pharmaceutical iron fortification. It is a low-cost, culturally acceptable, easy-to-prepare food-based intervention specifically designed for adolescent girls and combined with nutrition education.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Intervention ArmActive comparator 1 intervention
Group B: Control armNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in Hemoglobin Level (Hb)

Change in hemoglobin concentration (g/dL) from baseline to the end of the intervention comparing the iron-rich snack group with the control group by using Sahli's hemoglobinometer.

Time frame
12 weeks

Secondary outcomes

1

Anemia status

Anemia status assessed by Hb concentration (g/dl) using Sahli's hemoglobinometer, according to WHO 2024 criteria, cutoff of \<12.0g/dl for anemia in non pregnant females aged 15-65 years, mild anemia 11.0-11.9 g/dl, moderate anemia 8.0-10.9 g/dl, and severe anemia \<8.0 g/dl.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

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