Comparison Of Efficacy Of Iron Polymaltose Complex And Ferrous Sulphate In Iron Deficiency Anemia In Pediatric Patients

December 17, 2024 updated by: Arooj Khan

Comparison Of Efficacy Of Iron Polymaltose Complex And Ferrous Sulphate In Iron Deficiency Anemia In Pediatric Patients With Iron Deficiency Anemia

This study aims to compare the efficacy of two iron preparation for the management of children presented with iron deficiency anemia. Ferrous sulphate and lron polymaltose (ferric form) are most commonly used preparations. Both drugs are easily available in market and are often recommended by pediatriclans. The efficacy, bioavail.tbilily, side effects and cost of these preparations vary. This study is designed to find out a drug with better efficacy that can be used for treatment of iron deficiency anemia in local population.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Anemia remains a condition with high prevalence in populations worldwide. It is predominantly associated with nutritional status and socioeconomic conditions or hereditary diseases. The majority of anemia cases are linked to iron deficiency-named iron-deficiency anemia resulting from low intake of iron-rich foods in the diet, or from substantial blood loss.

This study aims to compare the efficacy of two iron preparation for the management of children presented with iron deficiency anemia. Ferrous sulphate and lron polymaltose (ferric form) are most commonly used preparations. Both drugs are easily available in market and are often recommended by pediatriclans. The efficacy, bioavail.tbilily, side effects and cost of these preparations vary. This study is designed to find out a drug with better efficacy that can be used for treatment of iron deficiency anemia in local population.

Study Type

Interventional

Enrollment (Estimated)

198

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • Pakistan
    • KPK
      • Peshawar, KPK, Pakistan, 25000
        • Recruiting
        • Khyber Teaching Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Aimal Khan, MBBS

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

Yes

Description

Inclusion Criteria:

  • Patients having iron deficiency anemia

Exclusion Criteria:

  1. Patients diagnosed as congenital aplastic anemia or thalassemia (Determined from medical record).
  2. Patients who were transfused in previous 4 weeks (will be determined on history)
  3. Children having mal-absorption syndrome and diarrheal illnesses. (will be determined on history and medical record)
  4. Gastrointestinal bleeding suggested by history of hematemesis (bloody vomit), melena (black colored stools) or bloody stools.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A (Ferrous sulphate)
Group A will be given Ferrous sulphate in a dose of 6mg/kg/day of elemental iron once daily for 8 weeks orally in syrup form.
Drug: Ferrous sulfate
ferrous sulphate in a dose of 6mg/kg/day of elemental iron once daily for 8 weeks orally in syrup form.
Active Comparator: Group B (Iron Polymaltose complex)
Group B will be given Iron Polymaltose complex in a dose of 6mg/kg/day of elemental iron once daily orally for 8 weeks.
Drug: Iron Polymaltose Complex
Iron Polymaltose complex in a dose of 6mg/kg/day of elemental iron once daily orally for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase Of Hemoglobin Level
Time Frame: 8 weeks
Increase in Hemoglobin level measured by a Complete Blood Count as compared to pre treatment Hemoglobin
8 weeks

Collaborators and Investigators

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

Sponsor

Arooj Khan

Collaborators

Khyber Teaching Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 10, 2024

Primary Completion (Estimated)

December 25, 2024

Study Completion (Estimated)

January 10, 2025

Study Registration Dates

First Submitted

December 2, 2024

First Submitted That Met QC Criteria

December 17, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 17, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 591/DME/KMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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