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

Not Applicable

Recruiting

• Conditions: Iron Deficiency Anemia; Iron Deficiency, Anaemia in Children
• Interventions: Drug: Ferrous sulfate; Drug: Iron Polymaltose Complex

• Registration Number: NCT06742528
• Lead Sponsor: Arooj Khan

Brief Summary

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.

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 Timeline

• Study Start: 2024-01-10
• Status Verified: 2024-12
• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-17
• Last Update Submitted: 2024-12-17
• Study First Posted: 2024-12-19
• Last Update Posted: 2024-12-19
• Primary Completion: 2024-12-25
• Study Completion: 2025-01-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 198

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (Ferrous sulphate)	Ferrous sulfate	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.
Group B (Iron Polymaltose complex)	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.

Primary Outcome Measures

Name	Time	Method
Increase Of Hemoglobin Level	8 weeks	Increase in Hemoglobin level measured by a Complete Blood Count as compared to pre treatment Hemoglobin

Trial Locations

Locations (1)

Khyber Teaching Hospital; 🇵🇰 Peshawar, KPK, Pakistan