Status:
COMPLETED
Role of Extrarenal 1-Alpha-Hydroxylase in Patients With End Stage Renal Disease
Lead Sponsor:
University of Kansas
Conditions:
End-Stage Renal Disease
Eligibility:
All Genders
21-88 years
Phase:
NA
Brief 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
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 poten...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00677534
Start Date
May 1 2008
End Date
August 1 2009
Last Update
April 29 2014
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