Vitamin D Supplement Study for Stage Three and Four Chronic Kidney Disease (CKD) Patients
Condition: Chronic Kidney Disease Stage 3 and 4
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: Ergocalciferol; Cholecalciferol
Intervention description: 1.25mg weekly for 12 weeks then once a month for 3 months. or 1.25 weekly for 4 weeks then once a month for 5 months. or 1.25 monthly for 6 months; 1.25 weekly for 12 weeks then monthly for 3 months or 1.25 weekly for 4 weeks then monthly for 5 months or 1.25 monthly for 6 months
Intervention MeSH terms: Cholecalciferol; Vitamin D; Ergocalciferols
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: CKD; Vitamin D

Summary:

      The purpose of this study is to examine the effectiveness of vitamin D3 versus vitamin D2 in
      raising vitamin D levels and suppressing parathyroid hormone levels in patients with kidney
      disease who are not on dialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults ≥ 18 years

          -  Chronic kidney disease stage 3-4 (eGFR 15-59 mL/min/1.73m2 body surface area,
             calculated using the MDRD Study equation GFR calculator)

          -  Hypovitaminosis D (serum 25OHD < 31 ng/mL)

          -  Secondary hyperparathyroidism (Intact PTH > 70 pg/mL for stage 3, and iPTH > 110 pg/mL
             for stage 4)

        Exclusion Criteria:

          -  Initiation of vitamin D therapy between the time of the lab draw used for screening
             and the screening process

          -  History of liver failure

          -  History of intestinal malabsorption or chronic diarrhea

          -  Serum calcium level greater than 10.2 mg/dL

          -  Treatment with an activated vitamin D formulation (calcitriol, doxercalciferol or
             paricalcitol) within the past 6 months

          -  Treatment with phenobarbital, phenytoin, rifampicin, sucralfate, steroids, digoxin, or
             other medications that could affect vitamin D metabolism

          -  Primary hyperparathyroidism, active of a prior history of such

          -  Active malignancy excluding basal cell or localized squamous cell skin cancer

          -  Subject is pregnant (e.g. positive HCG test) or breast-feeding

          -  Refusal to use highly effective contraceptive measures (as determined by the
             investigator) throughout the treatment phase of the study

          -  Serum phosphorus level greater than 4.5 or treatment with an oral phosphate binder
             within the past 6 months

          -  Treatment with cinacalcet or other calcimimetic within the past 6 months

          -  Anticipated dialysis within 6 months after randomization

          -  Inability to swallow tablets

          -  Known sensitivity, intolerance, or other adverse response to the study drugs which
             would prevent compliance with study medication

          -  Have an unstable medical condition, defined as having been hospitalized within 30 days
             before screening, the expectation of recurrent hospital admissions or life expectancy
             of less than 6 months in the judgment of the investigator

          -  Subject is currently enrolled in, or fewer than 30 days have passed since subject has
             completed another investigational device or drug study(s); or subject is receiving
             another investigational agent(s).

          -  Current treatment with vitamin D 50,000 IU