Oral Iron in Children With Chronic Kidney Disease

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT03991169
Phase
PHASE4
Status
Recruiting
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Conditions

  • Chronic Kidney Diseases
  • Chronic Kidney Insufficiency

Eligibility Criteria

Sex
ALL
Age
1 Year - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Ferrous Sulfate — DRUG
    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.

Study Details

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.

Key Dates

Start date
Apr 19, 2019
Status verified
Aug 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Change in muscle strength [ Time Frame: 0 and 3 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Weill Cornell Medicine / New York Presbyterian HospitalNew YorkNew York10065
Akeem Noziere, B.S.
[email protected]
646-962-8313
Oleh Akchurin, M.D. (PRINCIPAL_INVESTIGATOR)
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Jill Loguidice
[email protected]
267-425-4541
Amy Kogon, M.D., M.P.H. (PRINCIPAL_INVESTIGATOR)

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