Clinical trial NCT01173848: Vitamin D Supplement Study for Stage Three and Four Chronic Kidney Disease (CKD) Patients
Official title: A Randomized Study to Evaluate the Effectiveness of Cholecalciferol Versus Ergocalciferol Following Kidney Disease Outcomes Quality Initiative (K/DOQI) Guidelines for Vitamin D Therapy in Stages 3 & 4 Chronic Kidney Disease (CKD) Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Chronic Kidney Disease Stage 3 and 4
Keywords: CKD
Vitamin D
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2010-08-02
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 not on dialysis.

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 randomization outcome. The number of pills dispensed and medication instructions will be determined by their 25OHD level and K/DOQI guidelines. Both Study personnel and subject will be blinded to randomization group.

The treatment phase will be 24 weeks in duration with lab visits every 6 weeks. All laboratory specimens will be drawn either at CCF Main hospital labs or at a CCF family Health center lab. Subjects will be have telephone interviews at week 4, 10, 16, 22 and possibly at weeks 28 and 34.

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

Primary outcomes:
measure: Subjects Achieving Normal Vitamin D Levels
timeFrame: within 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: James F Simon, M.D.
role: PRINCIPAL_INVESTIGATOR
References: