Two Vitamin D Dosing Strategies in Children With Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      Vitamin D deficiency is common in the general population and more common in children with
      chronic kidney disease. Vitamin D is very important for bone health, especially in children
      with chronic kidney disease. To date, several studies using different doses of vitamin D have
      been tried to correct vitamin D deficiency, but none has been completely successful. The
      investigators are comparing two different doses of vitamin D to determine which one is more
      effective at correcting and maintaining normal blood levels of vitamin D. The investigators
      hypothesize that a higher percentage of children receiving a higher dose of vitamin D will be
      vitamin D replete at the end of 6 months.

      This study will enroll 80 children 9 to 18 years old who have chronic kidney disease (CKD)
      and can take pills. They will be enrolled from Chronic Renal Insufficiency Clinic, the
      Hemodialysis Unit, Peritoneal Dialysis Clinic and Transplant Clinic at Children's Healthcare
      of Atlanta.
    

Detailed description: 
      Vitamin D has a critical role in bone metabolism. In addition, there is increasing evidence
      that vitamin D has an important role in many other areas, including cardiovascular health,
      immune function, and prevention of autoimmune diseases and certain malignancies. In patients
      with CKD, there are a variety of abnormalities in mineral metabolism that lead to bone
      disease.

      After the investigators obtain informed consent and assent, children will be randomly
      assigned to either low dose (1000 units daily) or high dose (4000 units daily) vitamin D
      pills (50% in each group). Participants will take vitamin D capsules every day for for 6
      months. Vitamin D levels will be obtained at baseline, 3 months and 6 months. The study
      visits will be at the same time as routine clinic visits when the children are having blood
      drawn for routine care. At the end of the study, the investigators will compare the
      percentage of patients who have normal vitamin D levels at 6 months in the two groups. The
      investigators will also describe the percentage of patients who have elevated or low levels
      of trace elements.

      The two doses of vitamin D in this study are within the dosing range recommended by the
      Institute of Medicine, and thus the investigators do not anticipate any adverse effects.
      Vitamin D toxicity could theoretically occur, and an elevated vitamin D level at 3 months
      would be an indication to withdraw a patient from the study.
    

Intervention name(s): 1000 IU of Vitamin D3; 4000 IU of Vitamin D3
Intervention type(s): Drug; Drug
Intervention description(s): 1000 IU of Vitamin D will be administered in capsule form, once daily.; 4000 IU of Vitamin D will be administered in capsule form, once daily.
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment