Phase 2 N=34 Randomized Treatment

Vitamin D as a Modifier of Serum Hepcidin in Children With Chronic Kidney Disease

Anemia of Chronic Kidney Disease

Bottom Line

View on ClinicalTrials.gov: NCT01532349 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2017

Primary outcome: Primary: Change in Serum Hepcidin With Vitamin D Intervention for Children With Chronic Kidney Disease — 48.2; 75.4 ng/ml

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Cholecalciferol (Drug)
Age: Pediatric, Adult · 1+ yrs
Sex: All
Sponsor: Johns Hopkins University
Primary completion: Apr 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Serum Hepcidin With Vitamin D Intervention for Children With Chronic Kidney Disease	48.2; 75.4	—

Summary

This research is being done to study the effectiveness of vitamin D (cholecalciferol) to modify hepcidin levels in children with chronic kidney disease (CKD). Anemia is a common problem in children with CKD. Anemia is when the body does not have enough healthy red blood cells. Hepcidin is a protein in the blood which interferes with the body's production of red blood cells. This study will see if vitamin D lowers hepcidin levels in children and young adults with CKD. If so, it could be used as an additional treatment for anemia in these children, in addition to the current therapies already in use including iron supplements and erythropoietin. People between the ages of 1 and 21 with CKD may be considered for this study.

Eligibility Criteria

Inclusion Criteria

Clinical diagnosis of stage 2-5 Chronic Kidney Disease (estimated glomerular filtration rate [GFR] between 15 and 60 ng/mL which could be associated with increased risk of vitamin D toxicity

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Data sourced from ClinicalTrials.gov (NCT01532349). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.