Vitamin D Supplement Study for Stage Three and Four Chronic Kidney Disease (CKD) Patients

• Status: Terminated
• Trial end date: 2011-10-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

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