- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00677534
Role of Extrarenal 1-Alpha-Hydroxylase in Patients With End Stage Renal Disease
April 10, 2014 updated by: Jason Stubbs, MD, University of Kansas
Exploring the Role of Extrarenal 1-Alpha-Hydroxylase in Patients With End Stage Renal Disease
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
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 88 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Cholecalciferol (Vitamin D)
|
50,000 Units PO Twice weekly for 8 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Monocyte VDR Expression With Vitamin D Therapy
Time Frame: Change from End of Washout to Week 12
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jason Stubbs, MD, University of Kansas Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (Actual)
August 1, 2009
Study Completion (Actual)
August 1, 2009
Study Registration Dates
First Submitted
May 12, 2008
First Submitted That Met QC Criteria
May 13, 2008
First Posted (Estimate)
May 14, 2008
Study Record Updates
Last Update Posted (Estimate)
April 29, 2014
Last Update Submitted That Met QC Criteria
April 10, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11225 (DAIDS ES Registry ID)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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