Oral Iron in Children With Chronic Kidney Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-21
SponsorWeill Medical College of Cornell University
About this trial
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 criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Ferrous Sulfate
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Weill Medical College of Cornell University
Lead sponsor
Children's Hospital of Philadelphia
Collaborator
Source ClinicalTrials.gov