Vitamin D Repletion in Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00772772
• Other study ID #: MAP-0626
• Status: Completed
• Phase: Phase 0
• First received: October 13, 2008
• Last updated: January 6, 2015
• Start date: March 2008
• Est. completion date: October 2009

Study information

• Verified date: January 2015
• Source: Rockefeller University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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)

Locations

Country	Name	City	State
United States	Rockefeller University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Rockefeller University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Endotoxin Activity	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).	baseline and 8 weeks	No
Secondary	Blood Pressure		after 8 weeks of vitamin D therapy	No
Secondary	Intestinal Permeability		after 8 weeks of vitamin D therapy	No
Secondary	Nuclear Magnetic Resonance (NMR) Lipoprotein Profile		after 8 weeks of vitamin D therapy	No
Secondary	25-hydroxy Vitamin D (25-OH Vitamin D)	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.	after 8 weeks of vitamin D therapy	No
Secondary	1, 25-OH Vitamin D		after 8 weeks of vitamin D therapy	No