RECRUITING

Oral Iron in Children With Chronic Kidney Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2019-04-19
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03991169

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.

Ages Eligible for Study:1 Year to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 1-21 years old (muscle strength will be assessed only in children \>3 year old)
  2. * Estimated glomerular filtration rate (GFR) \< 90 ml/min/1.73m2 by bedside Schwartz formula \[height (cm) \*0.413 / serum creatinine (mg/dL)\]
  3. * Hemoglobin (Hb) more or equal than 9.0 at the previous clinic visit
  4. * 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)
  1. * Transferrin saturation \<5%
  2. * Serum ferritin \< 10 ng/mL
  3. * Iron therapy or erythrocyte stimulating agents (erythropoietin) therapy within 3 months prior to randomization
  4. * Blood transfusion within 4 months prior to enrollment
  5. * Children on hemodialysis
  6. * Rapidly deteriorating kidney function or expectation for transplantation or dialysis in less than 3 months
  7. * Pregnancy and breast-feeding

Contacts and Locations

Study Contact

Christopher Tapia, B.S.
CONTACT
212-746-4957
cht4005@med.cornell.edu

Principal Investigator

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

Study Locations (Sites)

Weill Cornell Medicine / New York Presbyterian Hospital
New York, New York, 10065
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-04-19
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2019-04-19
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Anemia
  • Iron
  • Children
  • Chronic kidney disease (CKD)
  • Appetite
  • Physical activity
  • Muscle strength

Additional Relevant MeSH Terms

  • Chronic Kidney Insufficiency
  • Chronic Kidney Diseases