Vitamin D Repletion in Chronic Kidney Disease

Rockefeller University

Status and phase

Completed

Early Phase 1

Conditions

Chronic Kidney Disease

Treatments

Drug: Vitamin D3

Study type

Interventional

Funder types

Other

Identifiers

NCT00772772

MAP-0626

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

50 to 80 years old

Volunteers

Accepts Healthy Volunteers

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