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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01173848
First received: July 30, 2010
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Chronic Kidney Disease Stage 3 and 4
Drug: Ergocalciferol
Drug: Cholecalciferol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Percent of subjects achieving normal vitamin D levels. [ Time Frame: within 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: July 2010
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01173848

Contacts
Contact: Rita Brienza, R.N., B.S.N 216-444-0122 brienzr@ccf.org
Contact: Michelle Garcia, R.N., B.S.N 216-444-7753 garciam1@ccf.org

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

No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01173848     History of Changes
Other Study ID Numbers: Cleveland Clinic
Study First Received: July 30, 2010
Last Updated: July 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
CKD
Vitamin D

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

ClinicalTrials.gov processed this record on October 01, 2014