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Oral Iron in Children With Chronic Kidney Disease

NCT03991169 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-08-11

No results posted yet for this study

Summary

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

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.

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-19
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03991169 on ClinicalTrials.gov