Vitamin D Repletion in Chronic Kidney Disease
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Effect of Vitamin D3 Repletion in Chronic Kidney Disease Stage 3|
- Change in Endotoxin Activity [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]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).
- Blood Pressure [ Time Frame: after 8 weeks of vitamin D therapy ] [ Designated as safety issue: No ]
- Intestinal Permeability [ Time Frame: after 8 weeks of vitamin D therapy ] [ Designated as safety issue: No ]
- Nuclear Magnetic Resonance (NMR) Lipoprotein Profile [ Time Frame: after 8 weeks of vitamin D therapy ] [ Designated as safety issue: No ]
- 25-hydroxy Vitamin D (25-OH Vitamin D) [ Time Frame: after 8 weeks of vitamin D therapy ] [ Designated as safety issue: No ]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.
- 1, 25-OH Vitamin D [ Time Frame: after 8 weeks of vitamin D therapy ] [ Designated as safety issue: No ]
|Study Start Date:||March 2008|
|Study Completion Date:||October 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Experimental: Vitamin D3
Vitamin D3 30,000 international units orally per week for 8 weeks
Drug: Vitamin D3
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)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00772772
|United States, New York|
|New York, New York, United States, 10065|
|Principal Investigator:||Manish Ponda, MD||Rockefeller University|