Iron Deficiency Anemia in ChildrenPhase 2NCT07657091
COMPARISON OF EFFICACY OF ORAL VS IV IRON THERAPY IN CHILDREN AGED 12-59 MONTHS, WITH IRON DEFICIENCY ANEMIA
A Phase 2 study testing Oral ferrous sulfate and iron sucrose in people with Iron Deficiency Anemia in Children, run by Kharadar General Hospital at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 59 months
- Conditions the study is for
- Iron Deficiency Anemia in Children
- What is being tested?
- Oral ferrous sulfate and iron sucrose
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2027to 30 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- . 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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.
- Conditions
- Iron Deficiency Anemia in Children
- Being tested
- Oral ferrous sulfate, iron sucrose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral ferrous sulfateDrug
Administration of oral ferrous sulfate at a dose of 3-6 mg/kg/day of elemental iron for treatment of iron deficiency anemia.
iron sucroseDrug
Administration of intravenous iron sucrose according to the calculated iron deficit under medical supervision. (Ganzoni formula)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Oral ferrous sulfate; Drug: iron sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
increase in hb from baseline
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start1 Jan 2027 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency Anemia in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kharadar General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657091
- Sponsor's protocol ID
- KGH-ERB:2026/02
- Status last verified
- May 2026
- First submitted
- 2 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lozoff B. Iron deficiency and child development. Food Nutr Bull. 2007 Dec;28(4 Suppl):S560-71. doi: 10.1177/15648265070284S409.
PubMed 18297894
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF EFFICACY OF ORAL VS IV IRON THERAPY IN CHILDREN AGED 12-59 MONTHS, WITH IRON DEFICIENCY ANEMIA
- ClinicalTrials.gov ID
- NCT07657091
- Acronym / sponsor ID
- KGH-ERB:2026/02
- Conditions
- Iron Deficiency Anemia in Children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kharadar General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral iron group | Active comparator | Drug: Oral ferrous sulfate, Drug: iron sucroseParticipants 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 sucroseParticipants 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. |
Who may qualify
- Ages
- 12 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- . 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral ferrous sulfateAdministration of oral ferrous sulfate at a dose of 3-6 mg/kg/day of elemental iron for treatment of iron deficiency anemia. | Drug | IV IRON GROUP, Oral iron group |
| iron sucroseAdministration of intravenous iron sucrose according to the calculated iron deficit under medical supervision. (Ganzoni formula) | Drug | IV IRON GROUP, Oral iron group |
Primary outcome
increase in hb from baseline
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Background: PubMed 18297894Lozoff B. Iron deficiency and child development. Food Nutr Bull. 2007 Dec;28(4 Suppl):S560-71. doi: 10.1177/15648265070284S409.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral ferrous sulfate and iron sucrose in people with Iron Deficiency Anemia in Children, run by Kharadar General Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
increase in hb from baseline (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07657091, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.