Role of Extrarenal 1-Alpha-Hydroxylase in Patients With End Stage Renal Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jason Stubbs, MD, University of Kansas
ClinicalTrials.gov Identifier:
NCT00677534
First received: May 12, 2008
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

The goal of this study is to evaluate the role of nutritional Vitamin D deficiency as a potential contributor to the morbidity witnessed in patients with end-stage renal disease


Condition Intervention
End-Stage Renal Disease
Drug: Cholecalciferol

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exploring the Role of Extrarenal 1-Alpha-Hydroxylase in Patients With End Stage Renal Disease

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Change in Monocyte VDR Expression With Vitamin D Therapy [ Time Frame: Change from End of Washout to Week 12 ] [ Designated as safety issue: No ]
    Monocytes will be analyzed pre- and post-cholecalciferol by flow cytometry to measure changes in monocyte VDR expression. Unit of measure is represented by mean florescence intensity (MFI), which is a relative measure.


Enrollment: 7
Study Start Date: May 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Cholecalciferol (Vitamin D)
Drug: Cholecalciferol
50,000 Units PO Twice weekly for 8 weeks
Other Name: Vitamin D, ergocalciferol

Detailed Description:

The goals of this study are to elucidate the function of extrarenal 1 alpha-hydroxylase activity in the setting of renal failure and to evaluate the role of nutritional vitamin D deficiency as a potential contributor to monocyte-associated inflammatory pathways in patients with end-stage renal disease (ESRD). This study will consist of patients on chronic maintenance hemodialysis three times per week who have been identified to have nutritional vitamin D deficiency. After consent for study enrollment, patients will undergo a 4 week washout period of all active vitamin D supplementation. After washout is complete, an blood sample will be obtained for baseline 25(OH)D levels and monocyte isolation for analysis by flow cytometry. Patients will then be started on cholecalciferol 50,000 IU twice weekly for 8 weeks. 25-vitamin D levels will be monitored midway through the treatment phase of the study and dosing adjusted as further described in detail within the protocol section. An additional blood sample will be drawn post-therapy for repeat 25(OH)D levels and monocyte isolation for flow cytometry analysis.

  Eligibility

Ages Eligible for Study:   21 Years to 88 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • End-stage renal disease undergoing maintenance hemodialysis at KUMC outpatient hemodialysis unit
  • Dialysis vintage of at least 6 months duration
  • Nutritional vitamin D deficiency, defined as 25(OH)D <25 ng/ml
  • Age 21 to 88 years

Exclusion Criteria:

  • Active infection
  • Recent hospitalization for acute illness (within last 1 month)
  • Refusal to study participation
  • Poorly controlled secondary hyperparathyroidism (iPTH>500)
  • History of chronic inflammatory disease process, such as inflammatory bowel, rheumatoid arthritis, lupus, etc.
  • Cinacalcet therapy
  • Previous allergy to ergocalciferol
  • History of parathyroidectomy
  • Current treatment with immunosuppressant medications
  • Noncompliance with prescribed hemodialysis regimen (i.e. skipping treatments, ending sessions early)
  • Functional renal transplant within the last five years
  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: NCT00677534

Sponsors and Collaborators
University of Kansas
Investigators
Principal Investigator: Jason Stubbs, MD University of Kansas
  More Information

Publications:
Responsible Party: Jason Stubbs, MD, Assistant Professor, University of Kansas
ClinicalTrials.gov Identifier: NCT00677534     History of Changes
Other Study ID Numbers: 11225
Study First Received: May 12, 2008
Results First Received: June 11, 2012
Last Updated: April 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
Endstage renal disease
Vitamin D
Monocyte function

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
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 July 26, 2014