Vitamin D as a Modifier of Serum Hepcidin in Children With Chronic Kidney Disease
Condition: Anemia of Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: Cholecalciferol
Intervention description: Children will be randomly allocated to receive either cholecalciferol supplementation 4000 IU per day 400 IU/day. We are proposing a supplementation dose of 4000 IU/day in children with CKD, which is considered a safe dose by KDOQI standards; vitamin D2 doses as high as 10,000 IU/day have been given to French patients with CKD for > 1 year with no evidence of vitamin D toxicity. Cholecalciferol will be provided in both tablet and liquid form, based on the ability to tolerate and preference of the subject. Participants will be monitored for signs of 25D toxicity (hypercalcemia, hyperphosphatemia, hypercalciuria) during the follow up period of 1 month and 3 months from baseline.
Intervention MeSH terms: Cholecalciferol; Vitamin D
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 1 Year
Maximum age: 21 Years
Healthy volunteers: No
Keywords: chronic kidney disease; anemia

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 < 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

        Exclusion Criteria:

          -  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