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COMPARISON OF EFFICACY OF ORAL VS IV IRON THERAPY IN CHILDREN AGED 12-59 MONTHS, WITH IRON DEFICIENCY ANEMIA

17. juni 2026 opdateret af: Kharadar General Hospital

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan
        • Kharadar General Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Medicin: Oral ferrous sulfate
Administration of oral ferrous sulfate at a dose of 3-6 mg/kg/day of elemental iron for treatment of iron deficiency anemia.
Medicin: iron sucrose
Administration of intravenous iron sucrose according to the calculated iron deficit under medical supervision. (Ganzoni formula)
Aktiv komparator: 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.
Medicin: Oral ferrous sulfate
Administration of oral ferrous sulfate at a dose of 3-6 mg/kg/day of elemental iron for treatment of iron deficiency anemia.
Medicin: iron sucrose
Administration of intravenous iron sucrose according to the calculated iron deficit under medical supervision. (Ganzoni formula)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
increase in hb from baseline
Tidsramme: 6 months
6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Kharadar General Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. januar 2027

Primær færdiggørelse (Anslået)

30. juni 2027

Studieafslutning (Anslået)

30. juni 2027

Datoer for studieregistrering

Først indsendt

2. juni 2026

Først indsendt, der opfyldte QC-kriterier

17. juni 2026

Først opslået (Faktiske)

18. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KGH-ERB:2026/02

Plan for individuelle deltagerdata (IPD)

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