Vitamin D Repletion in Chronic Kidney Disease

Early Phase 1

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

Inclusion Criteria

Inclusion Criteria for Healthy volunteers

Inclusion Criteria for Medium-level Kidney Function volunteers

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

Arm && Interventions

Group	Intervention	Description
Vitamin D3	Vitamin D3	Vitamin D3 30,000 international units orally per week for 8 weeks

Primary Outcome Measures

Name	Time	Method
Change in Endotoxin Activity	baseline and 8 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Blood Pressure	after 8 weeks of vitamin D therapy
25-hydroxy Vitamin D (25-OH Vitamin D)	after 8 weeks of vitamin D therapy	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.
Nuclear Magnetic Resonance (NMR) Lipoprotein Profile	after 8 weeks of vitamin D therapy
Intestinal Permeability	after 8 weeks of vitamin D therapy
1, 25-OH Vitamin D	after 8 weeks of vitamin D therapy