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Vitamin D Repletion in Chronic Kidney Disease

Primary Purpose

Chronic Kidney Disease

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Vitamin D3

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Vitamin D3 repletion, levels of endotoxin, intestinal permeability, accelerated atherosclerosis

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Rockefeller University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vitamin D3

Arm Description

Vitamin D3 30,000 international units orally per week for 8 weeks

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Blood Pressure

Intestinal Permeability

Nuclear Magnetic Resonance (NMR) Lipoprotein Profile

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.

1, 25-OH Vitamin D

Full Information

NCT ID

NCT00772772

First Posted

October 13, 2008

Last Updated

January 6, 2015

Sponsor

Rockefeller University

1. Study Identification

Unique Protocol Identification Number

NCT00772772

Brief Title

Vitamin D Repletion in Chronic Kidney Disease

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rockefeller University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Kidney Disease

Keywords

Vitamin D3 repletion, levels of endotoxin, intestinal permeability, accelerated atherosclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vitamin D3

Arm Type

Experimental

Arm Description

Vitamin D3 30,000 international units orally per week for 8 weeks

Intervention Type

Drug

Intervention Name(s)

Vitamin D3

Other Intervention Name(s)

Vitamin D

Intervention Description

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)

Primary Outcome Measure Information:

Title

Change in Endotoxin Activity

Description

Time Frame

baseline and 8 weeks

Secondary Outcome Measure Information:

Title

Blood Pressure

Time Frame