Oral Iron in Children With Chronic Kidney Disease

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Kidney Insufficiency, Chronic Kidney Diseases

Intervention / Treatment
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* Drug: Ferrous Sulfate


Participation Criteria
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Eligibility Criteria
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Key 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 Key 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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Iron therapy<br>Participant will receive oral iron therapy. | Drug: Ferrous Sulfate<br>* 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.<br>* Other names: iron sulfate;|
| No Intervention: No oral iron therapy<br>Participant will not receive oral iron therapy for 3 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in muscle strength | Hand-grip strength measured by a dynamometer | 0 and 3 months | 
| Change in the percentage of transferrin saturation in the participants' blood | 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 | 0 and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sedentary time | Sedentary time (in minutes per day) will be measured by actigraphy. Actigraph is a monitor that looks like a wristband or a watch that measures and records body movements throughout the day. Participating children will wear actigraphs for 7 days in the beginning and 7 days at the conclusion of the study. | 0 and 3 months | 
| Change in the percent of skeletal muscle mass | Percent of skeletal muscle mass out of body weight will be measured using bio-electrical impedance analysis. | 0 and 3 months | 
| Change in eating behavior | Appetite / eating behavior assessed using Children's Eating Behavior Questionnaire (CEBQ). It is a parent-report measure comprised of 35 items, each rated as Never, Rarely, Sometimes, Often, Always. The answers will be grouped into the domains to assess eating styles of the participating children, such as: Enjoyment of food, Slowness in eating, Emotional under-eating, Food fussiness. | 0 and 3 months | 
| Change in quality of life: PROMIS | Quality of life will be assessed in the Fatigue, and Physical Activity domains using the Patient-Reported Outcomes Measurement Information System (PROMIS), developed by the National Institutes of Health. PROMIS measures use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. Higher scores will mean more Fatigue and more Physical Activity respectively. | 0 and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anemia, Iron, Children, Chronic kidney disease (CKD), Appetite, Physical activity, Muscle strength