Vitamin D Repletion in Chronic Kidney Disease

Study Overview
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Brief Summary
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The reason for doing this research is that people with kidney disease often suffer from heart disease. Why this happens is not fully known. A possible cause may be high blood levels of a substance made by bacteria called endotoxin. The blood levels of this substance are high in people with medium-level kidney disease. We want to know if replacing normal amounts of Vitamin D can help lower the levels of this substance. We also want to know if replacing normal amounts of Vitamin D is associated with other changes that may help heart disease. We hope that our research will help figure out if levels of this substance can be lowered by replacing normal amounts of Vitamin D. Normal subjects are enrolled to have a 'control' set for comparison purposes.

Detailed Description
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Your participation in this study requires: 4 visits to the outpatient clinic (including 1 screening visit) Providing a blood sample (less than 5 tablespoons) and a urine sample at each visit Taking a test to measure how leaky your gut is. This test requires that you drink a small amount of liquid (about 4 ounces) and then collect your urine for 6 hours after drinking the liquid.

Official Title
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The Effect of Vitamin D3 Repletion in Chronic Kidney Disease Stage 3

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Drug: Vitamin D3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion Criteria for Healthy volunteers Males and post-menopausal females, between the age of 50 -80. Vitamin D 25-OH level less than 20 ng/ml Inclusion Criteria for Medium-level Kidney Function volunteers Males and post-menopausal females, between the age of 50 -80. Chronic kidney disease stage 3 Vitamin D 25-OH level less than 20 ng/ml Exclusion Criteria: Serum calcium level >10.5 mg/dl Serum phosphorus level > 5.5 mg/dl Serum PTH level < 35 pg/ml Active infection including HIV, Hepatitis B or C History of recent acute infection ( within 1 month) Gastrointestinal disease resulting in significant GI dysfunction or malabsorption Hgb< 10 g/dL Current use of Coumadin Current use of Vitamin D >400 IU/day Current use of systemic steroids or other immunosuppressants History of malignancy not in remission (>6 months) History of current ethanol abuse or illicit drug use History of significant emotional disorder within the past 5 years Participation in an investigational drug study within one month of screening Have any other condition, which in the opinion of the investigator, should prohibit the participation in the study

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D3<br>Vitamin D3 30,000 international units orally per week for 8 weeks | Drug: Vitamin D3<br>* 2 single oral dose of Vitamin D3 30,000 international units and 8 weeks supply of Vitamin D3 (10,000 IU tablets, 3 pills to be taken by mouth as one dose weekly)<br>* Other names: Vitamin D;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Endotoxin Activity | Endotoxin Activity as measured by the Endotoxin Activity Assay. This measurement was made at baseline and after 8 weeks of therapy with Vitamin D3. The measurement of the assay is unitless. It is not based on an absolute amount of endotoxin, but rather the proportion of the theoretical maximal response of the patient and ranges from 0 (lowest) to 1 (highest). | baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure |  | after 8 weeks of vitamin D therapy | 
| Intestinal Permeability |  | after 8 weeks of vitamin D therapy | 
| Nuclear Magnetic Resonance (NMR) Lipoprotein Profile |  | after 8 weeks of vitamin D therapy | 
| 25-hydroxy Vitamin D (25-OH Vitamin D) | 25-OH Vitamin D levels were measured in patients with chronic kidney disease at baseline and after 8 weeks of treatment with Vitamin D3 30000 units weekly. | after 8 weeks of vitamin D therapy | 
| 1, 25-OH Vitamin D |  | after 8 weeks of vitamin D therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D3 repletion, levels of endotoxin, intestinal permeability, accelerated atherosclerosis