Vitamin D Supplement Study for Stage Three and Four Chronic Kidney Disease (CKD) Patients (UPGRADE)
This study is currently recruiting participants.
Verified January 2012 by The Cleveland Clinic
Sponsor:
The Cleveland Clinic
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01173848
First received: July 30, 2010
Last updated: January 19, 2012
Last verified: January 2012
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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: | July 2012 (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
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: | January 19, 2012 |
| 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 Kidney Failure, Chronic Urologic Diseases Renal Insufficiency Cholecalciferol Ergocalciferols |
Vitamin D Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on May 19, 2013