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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01173848
Recruitment Status : Terminated
First Posted : August 2, 2010
Results First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Information provided by (Responsible Party):
The Cleveland Clinic

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Stage 3 and 4 Drug: Ergocalciferol Drug: Cholecalciferol Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : July 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : October 18, 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Vitamin D2
Patients randomized to take vitamin D2
Drug: Ergocalciferol
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
Active Comparator: Vitamin D3
Patient's randomized to take Vitamin D3
Drug: Cholecalciferol
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

Primary Outcome Measures :
  1. Subjects Achieving Normal Vitamin D Levels [ Time Frame: within 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01173848

United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Principal Investigator: James F Simon, M.D. The Cleveland Clinic

Responsible Party: The Cleveland Clinic Identifier: NCT01173848     History of Changes
Other Study ID Numbers: Cleveland Clinic
First Posted: August 2, 2010    Key Record Dates
Results First Posted: April 4, 2017
Last Update Posted: April 4, 2017
Last Verified: July 2013

Keywords provided by The Cleveland Clinic:
Vitamin D

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents