Oral Iron in Children With Chronic Kidney Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ferrous Sulfate.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Insufficiency, Chronic Kidney Diseases. Basic parameters: 1 year — 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pilot Pragmatic Clinical Trial of Oral Iron Therapy in Children With Chronic Kidney Disease
Overview
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.
Interventions
- Drug Ferrous 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.
Primary outcome measures
- Change in muscle strength [Time frame: 0 and 3 months]
- Change in the percentage of transferrin saturation in the participants' blood [Time frame: 0 and 3 months]
Secondary outcome measures (4)
- Change in sedentary time [Time frame: 0 and 3 months]
- Change in the percent of skeletal muscle mass [Time frame: 0 and 3 months]
- Change in eating behavior [Time frame: 0 and 3 months]
- Change in quality of life: PROMIS [Time frame: 0 and 3 months]
Eligibility criteria
Inclusion criteria
- 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)
Children with transferrin saturation ≤ 20% AND serum ferritin ≤ 100 ng/mL will be randomized into one of the arms
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Weill Cornell Medicine / New York Presbyterian Hospital — New York
- Children's Hospital of Philadelphia — Philadelphia
Identifiers
NCT: NCT03991169 · 1812019836