Vitamin D Repletion in Chronic Kidney Disease

NCT ID: NCT00772772

Last Updated: 2015-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2009-10-31

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.

Conditions

Chronic Kidney Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vitamin D3

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

Group Type: EXPERIMENTAL

Vitamin D3

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: DRUG

Other Intervention Names

Vitamin D

Eligibility Criteria

Inclusion Criteria

• Males and post-menopausal females, between the age of 50 -80.
• Vitamin D 25-OH level less than 20 ng/ml

• 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rockefeller University

OTHER

Sponsor Role: lead

Responsible Party

Manish Ponda

Assistant Professor of Clinical Investigation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manish Ponda, MD

Role: PRINCIPAL_INVESTIGATOR

Rockefeller University

Locations

Rockefeller University

New York, New York, United States

Countries

United States

Other Identifiers

MAP-0626

Identifier Type: -

Identifier Source: org_study_id