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

NCT07657091 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: KGH-ERB:2026/02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Iron Deficiency Anemia in Children

Outcome Measures

Primary Outcomes (1)

• increase in hb from baseline

  6 months

Study Arms (2)

Oral iron group

ACTIVE COMPARATOR

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.

Drug: Oral ferrous sulfate; Drug: iron sucrose

IV IRON GROUP

ACTIVE COMPARATOR

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.

Drug: Oral ferrous sulfate; Drug: iron sucrose

Interventions

Oral ferrous sulfate DRUG

Administration of oral ferrous sulfate at a dose of 3-6 mg/kg/day of elemental iron for treatment of iron deficiency anemia.

IV IRON GROUP; Oral iron group

iron sucrose DRUG

Administration of intravenous iron sucrose according to the calculated iron deficit under medical supervision. (Ganzoni formula)

IV IRON GROUP; Oral iron group

Eligibility Criteria

• Age: 12 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kharadar General Hospital: lead

Study Sites (1)

Kharadar General Hospital

Karachi, Sindh, Pakistan

Location

Related Publications (1)

• Lozoff B. Iron deficiency and child development. Food Nutr Bull. 2007 Dec;28(4 Suppl):S560-71. doi: 10.1177/15648265070284S409.

  PMID: 18297894 BACKGROUND

Related Links

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MeSH Terms

Interventions

ferrous sulfate; Ferric Oxide, Saccharated

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 18, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 18, 2026

Record last verified: 2026-05

Locations

PA (1)