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

Completed · Phase 2

Conditions studied: Anemia of Chronic Kidney Disease

In brief

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.

Key facts

Study ID

NCT01532349

Run by

Johns Hopkins University

People needed

34

Starts

2012-05-01

Expected to finish

2015-04-01

Last updated by the study team

2017-06-14

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of stage 2-5 Chronic Kidney Disease (estimated glomerular filtration rate [GFR] between 15 and < 90 ml/min/1.73m2) based on the new bedside Schwartz formula estimation using serum creatinine and height [height in cm x 0.413/serum creatinine]
• 1-21 years of age
• Willingness and ability to provide informed consent and assent

You may not qualify if…

• Children less than 1 year of age (in whom risk of vitamin D toxicity may be increased) or greater than 21 years at time of study screening
• Children with a documented history of hypercalcemia or nephrolithiasis
• Children with GI tract discontinuity (ostomy)
• Current pregnancy or pregnancy within the last 12 months
• Children with known anemia-related disorders including sickle cell anemia, thalassemia
• Children with severe 25D deficiency (< 5 ng/mL) likely to be associated with severe morbidity and requiring prompt high dose vitamin D supplementation, or with 25D levels > 60 ng/mL which could be associated with increased risk of vitamin D toxicity

Where it is running

• Johns Hopkins University — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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