Status:
TERMINATED
Vitamin D Supplement Study for Stage Three and Four Chronic Kidney Disease (CKD) Patients
Lead Sponsor:
The Cleveland Clinic
Conditions:
Chronic Kidney Disease Stage 3 and 4
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
Brief 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...
Detailed Description
Subjects will be randomized and assigned to one of the treatment groups (D2 or D3). Subjects will be dispensed a supply of 1.25 mg cholecalciferol/ergocalciferol tablets, depending on their randomizat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 18 2011
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01173848
Start Date
July 1 2010
End Date
October 18 2011
Last Update
April 4 2017
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195