Comparison between daily versus alternate day iron therapy in children with anemia in chronic kidney disease

Daily versus alternate day dosing of iron therapy for anemia in CKD stage 2-4 in children of age group 2-18 years: An open labelled randomised control trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/095064

Enrollment

Registered

2025-09-18

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N18- Chronic kidney disease (CKD)

Interventions

Intervention1: Alternate day iron therapy: alternate day iron therapy(ferrous ascorbate) 6 mg/kg/dose for 3 months Control Intervention1: Daily iron therapy: Daily iron therapy(ferrous ascorbate) at 3

Eligibility

Inclusion criteria

Inclusion criteria: 1)Children with a diagnosis of anemia in CKD stage G2 4 with Ferritin less than 100 with transferrin saturation less than 40% or if ferritin is between 100-300 and transferrin saturation less than 25%. 2)Hemoglobin of less than 11.5g/dl(5-11 years), less than 12 g/dl(12-14 years), for girls of more than 15 years, hemoglobin less than 12 g/dl and for boys more than 15 years, haemoglobin of less than 13 g/dl.

Exclusion criteria

Exclusion criteria: 1) Current use or use within last 3 months of oral or intravenous iron preparations 2) Associated B12/folate deficiency 3) Blood transfusion within last 3 months 3) Associated hemolytic anemia- Sickle cell, thalassemia 4) Anemia attributed from blood loss(intestinal bleed or bleeding from any other sites)

Design outcomes

Primary

Measure	Time frame
To compare increase in transferrin saturation in alternate day iron therapy(6 mg/kg/dose) versus daily oral iron therapy (3 mg/kg/day) in children aged 2-18 years with CKD stage 2-4 over a 12 week period.Timepoint: 3 months	—

Secondary

Measure	Time frame
To compare adherence between 2 groupsTimepoint: 3 months;To compare hepcidin and IL6 level at onset and at 12 weeks between 2 groupsTimepoint: 3 months;To correlate between baseline Hb, RBC indices, ferritin, stage of CKD and PTH to response to oral iron therapyTimepoint: 3 months;To compare the change in hemoglobin between the two groups over the study periodTimepoint: 3 months;To assess the incidence and severity of adverse events gastrointestinal side effects (nausea, vomiting, abdominal pain, constipation) between each group.Timepoint: 3 months	—

Measure

Time frame

To compare adherence between 2 groupsTimepoint: 3 months;To compare hepcidin and IL6 level at onset and at 12 weeks between 2 groupsTimepoint: 3 months;To correlate between baseline Hb, RBC indices, ferritin, stage of CKD and PTH to response to oral iron therapyTimepoint: 3 months;To compare the change in hemoglobin between the two groups over the study periodTimepoint: 3 months;To assess the incidence and severity of adverse events gastrointestinal side effects (nausea, vomiting, abdominal pain, constipation) between each group.Timepoint: 3 months

—

Countries

India

Contacts

Public ContactDr Amber Kumar

AIIMS Bhopal

girish.pediatrics@aiimsbhopal.edu.in8642002229

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026