Effectiveness of Oral Iron Therapy in Iron Deficiency Anemia With Daily vs Alternate Day Dosing

November 24, 2025 updated by: Marryam Kaleem, University of Child Health Sciences and Children's Hospital, Lahore

Effectiveness of Intermittent Oral Iron Therapy vs Continuous Oral Iron Therapy in Treating Iron Deficiency Anemia Patients UpTo 5 Year of Age; a Randomized Control Trial

Treating iron deficiency anemia in children with daily and alternate day oral iron therapy

Study Overview

Detailed Description

Comparison of effectiveness of oral iron in daily and alternate group in children

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • University of child health science and the children hospital lahore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- Patients of both genders with ages in the range of 0 -60 months suffering from IDA as per operational definition.

Exclusion Criteria:

  • Who have already taken treatment for IDA during last 2-months as per history/clinical record.

Who have undergone recent blood transfusion during last 12-weeks as per history/clinical record.

Children with chronic kidney disease, chronic liver disease, cardiac failure or concomitant malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Continuous oral iron therapy
Oral iron daily dosing 6mg/kg/day
Continuous vs intermittent oral iron therapy to see the difference of Hemoglobin rose in both group
Other Names:
  • Daily dosing
Pattern of Rise in hemoglobin in alternate day doaung
Other Names:
  • Intermittent, alternate day dosing
Experimental: Intermittent oral iron
Oral iron therapy on alternate day with dose of 6mg /kg/day for 3 mons
Continuous vs intermittent oral iron therapy to see the difference of Hemoglobin rose in both group
Other Names:
  • Daily dosing
Pattern of Rise in hemoglobin in alternate day doaung
Other Names:
  • Intermittent, alternate day dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rise in hemoglobin level after oral iron
Time Frame: 3 months
Hemoglobin level change in g/dl
3 months
Change in Hemoglobin level
Time Frame: 3month
Hb rise in g/dl
3month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rise in ferritin level
Time Frame: 3 month
Ferritin level change in ng/ml
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2025

Primary Completion (Actual)

March 7, 2025

Study Completion (Actual)

May 7, 2025

Study Registration Dates

First Submitted

November 24, 2025

First Submitted That Met QC Criteria

November 24, 2025

First Posted (Actual)

December 5, 2025

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

November 24, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Confidentiality

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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