| Registry | NCT07657091 |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 2 |
| Study type | Interventional; randomized, factorial, masking: single, supportive care |
| Enrollment | 100 (Estimated) |
| Sponsor | Kharadar General Hospital (Other) |
| Conditions | Iron Deficiency Anemia in Children |
| Interventions | Oral ferrous sulfate, iron sucrose (Drug) |
| Dates | start 2027-01-01 (estimated), primary completion 2027-06-30 (estimated), completion 2027-06-30 (estimated), first posted 2026-06-18, last updated 2026-06-18 |
| Locations | 1 site in Pakistan |
Related Papers Related Patents Related Grants Related Experts
All trials for Iron Deficiency Anemia in Children All trials of Oral ferrous sulfate All trials of iron sucrose
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Oral iron group | Active comparator | Drug: Oral ferrous sulfate; Drug: iron sucrose | 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. |
| IV IRON GROUP | Active comparator | Drug: Oral ferrous sulfate; Drug: iron sucrose | 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. |
Sex: All, ages: 12 Months to 59 Months
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Kharadar General Hospital | Karachi, Sindh | Pakistan |