COMPARISON OF EFFICACY OF ORAL VS IV IRON THERAPY IN CHILDREN AGED 12-59 MONTHS, WITH IRON DEFICIENCY ANEMIA
Comparison of Efficacy of Oral versus Intravenous Iron Therapy in Children Aged 12-59 Months with Iron Deficiency Anemia: A Randomized Controlled Trial Iron deficiency anemia (IDA) remains one of the most common nutritional disorders among children worldwide and is a major public health concern in developing countries, including Pakistan. Children under five years of age are particularly vulnerable due to rapid growth and increased iron requirements. IDA can adversely affect cognitive development, motor performance, behavior, immunity, and overall growth.
Oral iron supplementation is currently the standard treatment for pediatric IDA because of its affordability and ease of administration. However, its effectiveness is often limited by gastrointestinal side effects, poor palatability, prolonged treatment duration, and poor adherence. Intravenous iron therapy offers an alternative approach that may provide faster correction of anemia and replenishment of iron stores while avoiding some of the limitations associated with oral therapy.
Although intravenous iron preparations have demonstrated promising results in several settings, comparative data among young children remain limited. This randomized controlled trial aims to compare the efficacy and safety of oral iron therapy and intravenous iron sucrose therapy in children aged 12-59 months with moderate iron deficiency anemia. The findings of this study may help identify the most effective and practical treatment strategy for this high-risk population.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Iron deficiency anemia is a leading cause of morbidity among children under five years of age and continues to contribute substantially to poor child health outcomes in low- and middle-income countries. Early childhood is a critical period for growth and neurodevelopment, and iron deficiency during this stage may result in long-term adverse effects on cognitive function, psychomotor development, behavior, and immunity.
Oral iron supplementation remains the standard treatment for iron deficiency anemia; however, treatment success is frequently affected by poor adherence resulting from gastrointestinal side effects, unpleasant taste, prolonged treatment duration, and inconsistent caregiver administration. These limitations may delay hematologic recovery and restoration of iron stores.
Intravenous iron sucrose has emerged as a potential alternative for the treatment of iron deficiency anemia. It allows direct replenishment of iron stores, may achieve a more rapid increase in hemoglobin levels, and eliminates issues related to gastrointestinal absorption and daily medication adherence. Despite these potential advantages, evidence comparing intravenous and oral iron therapy in young children is limited, particularly in resource-constrained settings.
This randomized controlled trial will evaluate and compare the effectiveness and safety of oral iron therapy and intravenous iron sucrose therapy in children aged 12-59 months diagnosed with moderate iron deficiency anemia. The study findings are expected to provide locally relevant evidence to support clinical decision-making and optimize treatment strategies for pediatric iron deficiency anemia.
Type d'étude
Inscription (Estimé)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Sindh
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Karachi, Sindh, Pakistan
- Kharadar General Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
Inclusion Criteria:•
. Age 12-59 months.
- Diagnosed with moderate iron deficiency anemia
- Hemoglobin level 7-9.9 g/dL
- Parents or guardians willing to provide informed consent
Exclusion Criteria:•
- Mild anemia and Severe anemia (Hb <7 g/dL)/ requiring blood transfusion
- Known hemoglobinopathies (e.g., thalassemia)
- Acute severe infection or inflammatory disease
- Previous iron therapy within the last 4 weeks/ Blood transfusion
- Known hypersensitivity to iron preparations
- Those who are not willing to participate.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Oral iron group
Participants assigned to this group will receive oral iron therapy according to the standard pediatric treatment protocol for moderate iron deficiency anemia.
Hemoglobin levels and clinical response will be monitored during the study period to assess the effectiveness and safety of oral iron supplementation.
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Administration of oral ferrous sulfate at a dose of 3-6 mg/kg/day of elemental iron for treatment of iron deficiency anemia.
Administration of intravenous iron sucrose according to the calculated iron deficit under medical supervision.
(Ganzoni formula)
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Comparateur actif: IV IRON GROUP
Participants assigned to this group will receive intravenous (IV) iron therapy according to the standard pediatric treatment protocol for moderate iron deficiency anemia.
Hemoglobin levels, iron status, and clinical response will be monitored throughout the study period to evaluate the effectiveness and safety of IV iron administration.
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Administration of oral ferrous sulfate at a dose of 3-6 mg/kg/day of elemental iron for treatment of iron deficiency anemia.
Administration of intravenous iron sucrose according to the calculated iron deficit under medical supervision.
(Ganzoni formula)
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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increase in hb from baseline
Délai: 6 months
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6 months
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Collaborateurs et enquêteurs
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Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- KGH-ERB:2026/02
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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