Vitamin D Repletion in Chronic Kidney Disease

This study has been completed.
Sponsor:
Information provided by:
Rockefeller University
ClinicalTrials.gov Identifier:
NCT00772772
First received: October 13, 2008
Last updated: May 11, 2011
Last verified: May 2011

October 13, 2008
May 11, 2011
March 2008
June 2009   (final data collection date for primary outcome measure)
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).
Endotoxin levels and activity [ Time Frame: after 8 weeks of vitamin D therapy ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00772772 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • NMR lipoprotein profile [ Time Frame: after 8 weeks of vitamin D therapy ] [ Designated as safety issue: No ]
  • 25-OH Vitamin D [ Time Frame: after 8 weeks of vitamin D therapy ] [ Designated as safety issue: No ]
  • 1, 25-OH vitamin D [ Time Frame: after 8 weeks of vitamin D therapy ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Vitamin D Repletion in Chronic Kidney Disease
The Effect of Vitamin D3 Repletion in Chronic Kidney Disease Stage 3

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.

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.
Interventional
Phase 0
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Kidney Disease
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)
Experimental: Vitamin D3
Vitamin D3 30,000 international units orally per week for 8 weeks
Intervention: Drug: Vitamin D3
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
October 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

Inclusion Criteria for Healthy volunteers (Currently Recruiting)

  • 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 (Closed to Recruitment)

  • 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
Both
50 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00772772
MAP-0626
No
Manish Ponda, MD, Rockefeller University
Rockefeller University
Not Provided
Principal Investigator: Manish Ponda, MD Rockefeller University
Rockefeller University
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP