NCT07798440

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress25%
Aug 2026Jan 2027

First Submitted

Initial submission to the registry

August 24, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

August 28, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2027

Last Updated

September 1, 2026

Status Verified

August 1, 2026

Enrollment Period

3 months

First QC Date

August 24, 2026

Last Update Submit

August 27, 2026

Conditions

Iron Deficiency Anemia (IDA)

Keywords

AnemiaIron rich snackAdolescent girlsHemoglobinRandomized controlled trial

Outcome Measures

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.

    12 weeks

Secondary Outcomes (1)

  • Anemia status

    12 weeks

Study Arms (2)

Intervention Arm

ACTIVE COMPARATOR

Participants will receive two 25g iron-rich balls daily for 12 weeks

Dietary Supplement: Iron Rich Bars

Control arm

NO INTERVENTION

Participants will continue their regular diet for 12 weeks

Interventions

Iron Rich BarsDIETARY_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.

Intervention Arm

Eligibility Criteria

Age16 Years - 18 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study is limited to female participants (adolescent girls) aged 16-18 years who meet the specified inclusion criteria.
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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
  • Available for baseline and post-intervention assessment

You may not qualify if:

  • Moderate and severe iron deficiency anemia requiring medical treatment
  • Currently taking iron supplements
  • Allergy to ingredients in iron rich balls
  • Having chronic GIT disorders
  • Pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Veterinary and Animal Sciences

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

  • Ali SA, Razzaq S, Aziz S, Allana A, Ali AA, Naeem S, Khowaja N, Ur Rehman F. Role of iron in the reduction of anemia among women of reproductive age in low-middle income countries: insights from systematic review and meta-analysis. BMC Womens Health. 2023 Apr 17;23(1):184. doi: 10.1186/s12905-023-02291-6.

    PMID: 37069552BACKGROUND

MeSH Terms

Conditions

Anemia, Iron-DeficiencyAnemia

Condition Hierarchy (Ancestors)

Anemia, HypochromicHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Dr. Qaisar Raza, Phd

    University of Veterinary and Animal Sciences Lahore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arfa Nasir Rasheed, Mphil Food and Nutrition

CONTACT

+923097387787arfanasir549@gmail.com

Dr.Qaisar Raza, Phd

CONTACT

+923002479044qaisar.raza@uvas.edu.pk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 24, 2026

First Posted

September 1, 2026

Study Start

August 28, 2026

Primary Completion (Estimated)

November 28, 2026

Study Completion (Estimated)

January 28, 2027

Last Updated

September 1, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared with other researchers due to participant confidentially and privacy considerations. Only aggregated, de-identified study results will be reported and shared.

Locations

PA(1)