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

ConditionsIron Deficiency Anemia Iron Deficiency, Anaemia in Children

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age6-5

SponsorArooj Khan

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients having iron deficiency anemia

Disqualifiers

Patients diagnosed as congenital aplastic anemia or thalassemia (Determined from medical record).

Patients who were transfused in previous 4 weeks (will be determined on history)

Children having mal-absorption syndrome and diarrheal illnesses. (will be determined on history and medical record)

Gastrointestinal bleeding suggested by history of hematemesis (bloody vomit), melena (black colored stools) or bloody stools.

Trial design

Design model

Parallel

Treatments tested in this trial

Ferrous sulfate
Drug
ferrous sulphate in a dose of 6mg/kg/day of elemental iron once daily for 8 weeks orally in syrup form.
Iron Polymaltose Complex
Drug
Iron Polymaltose complex in a dose of 6mg/kg/day of elemental iron once daily orally for 8 weeks.

Treatment groups

198 Participants

are divided into 2 treatment groups

Group A: Group A (Ferrous sulphate)Active comparator 1 intervention

Group B: Group B (Iron Polymaltose complex)Active comparator 1 intervention

Trial outcomes

Primary outcomes

Increase Of Hemoglobin Level

Increase in Hemoglobin level measured by a Complete Blood Count as compared to pre treatment Hemoglobin

Time frame

8 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Arooj Khan

Lead sponsor

Khyber Teaching Hospital

Sponsor institution

Khyber Teaching Hospital

Collaborator

Source ClinicalTrials.gov

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