search
Back to results

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

Primary Purpose

Chronic Kidney Disease Stage 3 and 4

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ergocalciferol
Cholecalciferol
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease Stage 3 and 4 focused on measuring CKD, Vitamin D

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Vitamin D2

Vitamin D3

Arm Description

Patients randomized to take vitamin D2

Patient's randomized to take Vitamin D3

Outcomes

Primary Outcome Measures

Subjects Achieving Normal Vitamin D Levels

Secondary Outcome Measures

Full Information

First Posted
July 30, 2010
Last Updated
March 30, 2017
Sponsor
The Cleveland Clinic
search

1. Study Identification

Unique Protocol Identification Number
NCT01173848
Brief Title
Vitamin D Supplement Study for Stage Three and Four Chronic Kidney Disease (CKD) Patients
Acronym
UPGRADE
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

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Terminated
Study Start Date
July 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
October 18, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease Stage 3 and 4
Keywords
CKD, Vitamin D

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D2
Arm Type
Active Comparator
Arm Description
Patients randomized to take vitamin D2
Arm Title
Vitamin D3
Arm Type
Active Comparator
Arm Description
Patient's randomized to take Vitamin D3
Intervention Type
Drug
Intervention Name(s)
Ergocalciferol
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Intervention Description
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 Measure Information:
Title
Subjects Achieving Normal Vitamin D Levels
Time Frame
within 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James F Simon, M.D.
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs