Vitamin D as a Modifier of Serum Hepcidin in Children With Chronic Kidney Disease (D-fense)
Anemia of Chronic Kidney Disease
About this trial
This is an interventional treatment trial for Anemia of Chronic Kidney Disease focused on measuring chronic kidney disease, anemia
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
Sites / Locations
- Johns Hopkins University
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
400 IU vitamin D
4000 IU vitamin D
Children will be randomly allocated to receive cholecalciferol supplementation 400 IU/day (2,800 IU/weekly), which is the recommended dietary allowance. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.
Children will be randomly allocated to receive cholecalciferol supplementation 4000 IU/day (28,000 IU weekly) according to the KDOQI recommended supplementation for children with mild 25D deficiency. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.