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

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

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Kidney Disease Stage 3 and 4
• Intervention / Treatment: Drug: Ergocalciferol; Drug: Cholecalciferol

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
• Enrollment (Actual): 19
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Subjects Achieving Normal Vitamin D Levels	within 24 weeks

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: James F Simon, M.D., The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (ACTUAL): September 1, 2011
• Study Completion (ACTUAL): October 18, 2011

Study Registration Dates

• First Submitted: July 30, 2010
• First Submitted That Met QC Criteria: July 30, 2010
• First Posted (ESTIMATE): August 2, 2010

Study Record Updates

• Last Update Posted (ACTUAL): April 4, 2017
• Last Update Submitted That Met QC Criteria: March 30, 2017
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Vitamin D; CKD
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Ergocalciferols
• Other Study ID Numbers: Cleveland Clinic