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Sponsored by: |
University of Kansas |
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Information provided by: | University of Kansas |
ClinicalTrials.gov Identifier: | NCT00677534 |
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 |
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End-Stage Renal Disease |
Drug: Cholecalciferol |
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 |
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 |
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1: Experimental
Vitamin D
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Drug: Cholecalciferol
50,000 Units PO Twice weekly for 8 weeks
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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.
Ages Eligible for Study: | 21 Years to 88 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Endstage renal disease Vitamin D Monocyte function |
Cholecalciferol Renal Insufficiency Vitamin D Urologic Diseases Renal Insufficiency, Chronic |
Ergocalciferols Kidney Failure, Chronic Kidney Diseases Kidney Failure |
Growth Substances Vitamins Physiological Effects of Drugs |
Bone Density Conservation Agents Micronutrients Pharmacologic Actions |