Oral Iron in Children With Chronic Kidney Disease

Description

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.

Conditions

Chronic Kidney Insufficiency, Chronic Kidney Diseases

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Study Overview

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Study Details

Study 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.

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

Oral Iron in Children With Chronic Kidney Disease

Condition
Chronic Kidney Insufficiency
Intervention / Treatment

-

Contacts and Locations

New York

Weill Cornell Medicine / New York Presbyterian Hospital, New York, New York, United States, 10065

Philadelphia

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

1 Year to 21 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Weill Medical College of Cornell University,

Oleh Akchurin, M.D., PRINCIPAL_INVESTIGATOR, Weill Cornell College of Medicine

Study Record Dates

2025-12-31