NCT03991169

Oral Iron in Children With Chronic Kidney Disease

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 1 Year – 21 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2019-04-19
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2019-06-19
• Last updated: 2025-08-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study