Oral Iron for Children with Chronic Kidney Disease

This study is looking at how oral iron, specifically Ferrous Sulfate, affects children aged 1 to 21 years old who have chronic kidney disease (CKD) and mild anemia (low red blood cell count). You might be able to join if your child's kidneys aren't working as well as they should (estimated glomerular filtration rate or GFR less than 90) and they have mild anemia. The study will compare children who receive Ferrous Sulfate to those who don't, over a 3-month period. Researchers will measure changes in muscle strength and the amount of iron in the blood (transferrin saturation) to see if the treatment is helpful. The study plans to enroll 40 participants.

Study design
This is a pilot study that will randomly assign 40 participants to either receive oral iron (Ferrous Sulfate) or no iron therapy. The study will last for 3 months.
What's involved
Participants will receive oral iron (Ferrous Sulfate) daily for 3 months, or no iron therapy. Muscle strength, physical activity, and eating behavior will be measured at the beginning and end of the 3-month study period.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 3 months, with measurements taken at the start and end of this period.

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NCT03991169

Oral Iron in Children With Chronic Kidney Disease

Recruiting
PHASE4Ages 1–21InterventionalTreatment
Weill Medical College of Cornell University
~40 participants
Updated 2025-08-11 on ClinicalTrials.gov
What's tested:Ferrous Sulfate

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in muscle strength
Measured over 0 and 3 months
+1 more outcome measured
Chronic Kidney Insufficiency
Chronic Kidney Diseases
2 sites across 2 states
New York1
Pennsylvania1
  • Oleh Akchurin, M.D. · PRINCIPAL_INVESTIGATOR · Weill Cornell College of Medicine

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Eligibility criteria

Inclusion

Age 1-21 years old (muscle strength will be assessed only in children \>3 year old)
Estimated glomerular filtration rate (GFR) \< 90 ml/min/1.73m2 by bedside Schwartz formula \[height (cm) \*0.413 / serum creatinine (mg/dL)\]
Hemoglobin (Hb) more or equal than 9.0 at the previous clinic visit
Hb less than 11.5 g/dL in children younger than 5 years Hb less than 12.0 g/dL in children 5-12 years Hb \<12.5 g/dL in children 12-15 yrs and females \>15 yrs. Hb \<13.5 g/dL in males \>15 years (all at the previous clinic visit)

Exclusion

Transferrin saturation \<5%
Serum ferritin \< 10 ng/mL
Iron therapy or erythrocyte stimulating agents (erythropoietin) therapy within 3 months prior to randomization
Blood transfusion within 4 months prior to enrollment
Children on hemodialysis
Rapidly deteriorating kidney function or expectation for transplantation or dialysis in less than 3 months
Pregnancy and breast-feeding
  • Change in muscle strength0 and 3 months

    Hand-grip strength measured by a dynamometer

  • Change in the percentage of transferrin saturation in the participants' blood0 and 3 months

    Transferrin saturation is a medical laboratory value, measured as a percentage. It is the value of serum iron concentration divided by the total iron-binding capacity. For instance, a value of 15% means that 15% of iron-binding sites of transferrin are being occupied by iron. Blood will be collected with the venopuncture used for clinically indicated blood tests at routine clinic visits