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(MAP-0626) Vitamin D Repletion in Chronic Kidney Disease

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The Effect of Vitamin D3 Repletion in Chronic Kidney Disease Stage 3 on Levels of Endotoxin, Intestinal Permeability and Markers of Accelerated Atherosclerosis

Principal Investigator:
Manish Ponda M.D.

Investigators:

Contact Information:
Clinical Research Support Office
The Rockefeller University
1230 York Avenue
New York , NY 10021
Telephone: 1800-RUCARES
Email: rucares@rockefeller.edu
Enrollment Status:
Closed to Enrollment

Brief Summary of Protocol:
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.



Detailed Description of Protocol:
This study has two tracks. Participants will be asked to participate in one of the tracks.

Track One:
· 2 visits to the outpatient clinic (including 1 screening visit)
· Providing a blood sample (less than 5 tablespoons), a fasting blood sample (less than 5 tablespoons) and a urine sample

Track Two:
· 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.





    What specifically makes a person eligible for the study?
    You may be eligible to enter this study:



    1. Males and post-menopausal females, between the age of 50 -80.

    2. Chronic kidney disease stage 3 or Healthy Volunteer

    Gender:
    Both

    Age(s):
    50-80 years of age

    Children permitted to participate:
    No

    Potential Benefits.....
    You will receive Vitamin D to replace normal amounts of Vitamin D in your body.

    Also, others may benefit in the future from what we learn from this study.



    Compensation:
    There is no cost to you for being in this research study.

    Compensation is provided.

Contact Information