NCT00772772

Vitamin D Repletion in Chronic Kidney Disease

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Rockefeller University · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-06-01
• Completion: 2009-10-01
• First posted: 2008-10-15
• Last updated: 2015-01-15
• Results posted: 2011-06-13

Locations

1 site across 1 country: United States