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

End-Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00677534
• Other study ID #: 11225
• Status: Completed
• Phase: N/A
• First received: May 12, 2008
• Last updated: April 10, 2014
• Start date: May 2008
• Est. completion date: August 2009

Study information

• Verified date: April 2014
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 88 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Drug:
• Cholecalciferol
50,000 Units PO Twice weekly for 8 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

References & Publications (1)

Stubbs JR, Idiculla A, Slusser J, Menard R, Quarles LD. Cholecalciferol supplementation alters calcitriol-responsive monocyte proteins and decreases inflammatory cytokines in ESRD. J Am Soc Nephrol. 2010 Feb;21(2):353-61. doi: 10.1681/ASN.2009040451. Epub — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Monocyte VDR Expression With Vitamin D Therapy	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.	Change from End of Washout to Week 12	No