Recruiting

Oral Iron

Sponsor:

Weill Medical College of Cornell University

Code:

NCT03991169

Conditions

Chronic Kidney Insufficiency

Chronic Kidney Diseases

Eligibility Criteria

Sex: All

Age: 1 - 21

Healthy Volunteers: Not accepted

Interventions

Ferrous Sulfate

Study Details

Brief 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

Study ID

NCT03991169

Start date

Apr 19, 2019

Status verified date

Aug, 2025

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 21

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Oral Iron therapy

Participant will receive oral iron therapy.

no intervention: No oral iron therapy

Participant will not receive oral iron therapy for 3 months.

Interventions

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.

Primary outcome measure

  • Change in muscle strength [ Time Frame: 0 and 3 months ]
  • Change in the percentage of transferrin saturation in the participants' blood [ Time Frame: 0 and 3 months ]

Central Contacts and Locations

Central contacts

Akeem Noziere, B.S.

646-962-8313akn4001@med.cornell.edu

Locations

Weill Cornell Medicine / New York Presbyterian Hospital

Recruiting

New York, New York, United States, 10065

Contacts

Akeem Noziere, B.S.

646-962-8313akn4001@med.cornell.edu

Principal Investigator:

Oleh Akchurin, M.D.

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Jill Loguidice

267-425-4541loguidicej@chop.edu

Principal Investigator:

Amy Kogon, M.D., M.P.H.

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Aug 11, 2025

Last verified

Aug, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2025-08-11.