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Role of Extrarenal 1-Alpha-Hydroxylase in Patients With End Stage Renal Disease
This study is enrolling participants by invitation only.
Sponsored by: University of Kansas
Information provided by: University of Kansas
ClinicalTrials.gov Identifier: NCT00677534
  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

Drug Information available for: Vitamin D Ergocalciferol Cholecalciferol
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title: Exploring the Role of Extrarenal 1-Alpha-Hydroxylase in Patients With End Stage Renal Disease

Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Changes in RNA expression as a result of ergocalciferol [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: May 2008
Estimated Study Completion Date: September 2008
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Vitamin D
Drug: Cholecalciferol
50,000 Units PO Twice weekly for 8 weeks

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 the morbidity witnessed 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 baseline blood sampling prior to a 4 week washout period of all active vitamin D supplementation. After washout is complete, an additional blood sample will be obtained. These two initial blood samples will be saved for later isolation of peripheral monocytes for measurement of mRNA expression. Additionally, vitamin D levels will be measured from the second sample to establish baseline levels prior to treatment. After this baseline sampling, patients will be started on cholecalciferol therapy 50,000 IU twice weekly. Serum 25-vitamin D levels will be monitored throughout study and dosing adjusted as further described in detail within the protocol section. After 8 weeks of therapy with cholecalciferol, post-treatment blood sample will be taken in order to once again isolate peripheral monocytes and measure gene response activity.

  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
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

Responsible Party: University of Kansas Medical Center ( Jason Stubbs MD )
Study ID Numbers: 11225
Study First Received: May 12, 2008
Last Updated: September 15, 2008
ClinicalTrials.gov Identifier: NCT00677534  
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Cholecalciferol
Renal Insufficiency
Vitamin D
Urologic Diseases
Renal Insufficiency, Chronic
Ergocalciferols
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:
Growth Substances
Vitamins
Physiological Effects of Drugs
Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009