RecruitingPhase 4NCT03991169

Oral Iron in Children With Chronic Kidney Disease

Pilot Pragmatic Clinical Trial of Oral Iron Therapy in Children With Chronic Kidney Disease


Sponsor

Weill Medical College of Cornell University

Enrollment

40 participants

Start Date

Apr 19, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

This is a pilot clinical trial of oral iron therapy in children with chronic kidney disease (CKD) and mild anemia. Eligible children will be randomized into a standard of care (iron sulfate) arm vs. no iron therapy arm for 3 months. The outcomes will include muscle strength, physical activity, and changes in eating behavior, which will be measured at enrollment and at the end of the study period.


Eligibility

Min Age: 1 YearMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether oral iron supplements can safely and effectively treat iron deficiency and anemia in children with chronic kidney disease (CKD). Iron deficiency in CKD can worsen anemia and slow development. **You may be eligible if...** - Your child is between 1 and 21 years old - Your child has chronic kidney disease (kidney function below 90% of normal) - Your child's hemoglobin is below normal for their age but not dangerously low (at least 9.0 g/dL) - Your child has low iron stores (transferrin saturation at or below 20% AND ferritin at or below 100 ng/mL) **You may NOT be eligible if...** - Iron stores are critically low (transferrin saturation below 5% or ferritin below 10 ng/mL) - Your child is currently on iron therapy or a red blood cell stimulating drug - Other specified lab criteria are not met Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFerrous Sulfate

Oral iron will be given in the form of immediate-release iron sulfate, 3-6 mg/kg/day of elemental iron to children with body weight ≤43 kg, and 65 mg of elemental iron (325 mg of iron sulfate) to children with body weight \>43 kg.


Locations(2)

Weill Cornell Medicine / New York Presbyterian Hospital

New York, New York, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

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NCT03991169


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