Vitamin D Repletion in Chronic Kidney Disease - Full Text View

Sponsored by:	Rockefeller University
Information provided by:	Rockefeller University
ClinicalTrials.gov Identifier:	NCT00772772

Purpose

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.

Condition	Intervention
Chronic Kidney Disease	Drug: Vitamin D3

Drug Information available for: Vitamin D Ergocalciferol Cholecalciferol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	The Effect of Vitamin D3 Repletion in Chronic Kidney Disease Stage 3

Further study details as provided by Rockefeller University:

Primary Outcome Measures:

Endotoxin levels and activity [ Time Frame: after 8 weeks of vitamin D therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	12
Study Start Date:	March 2008
Estimated Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Vitamin D3: Experimental	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)

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.

Eligibility

Ages Eligible for Study:	50 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males and post-menopausal females, older than 50 years of age
CKD stage 3
Vitamin D 25-OH level <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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772772

Contacts

Contact: Caryne Roey

212-327-8409

croey@rockefeller.edu

Locations

United States, New York
Rockefeller University	Recruiting
New York, New York, United States, 10065
Principal Investigator: Manish Ponda, MD

Sponsors and Collaborators

Rockefeller University

Investigators

Principal Investigator:

Manish Ponda, MD

Rockefeller University

More Information

Responsible Party:	Rockefeller University ( Manish Ponda, MD )
Study ID Numbers:	MAP-0626
Study First Received:	October 13, 2008
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00772772
Health Authority:	United States: Institutional Review Board

Keywords provided by Rockefeller University:

Vitamin D3 repletion
levels of endotoxin
intestinal permeability
accerlerated atherosclerosis

Study placed in the following topic categories:

Atherosclerosis
Cholecalciferol
Renal Insufficiency
Vitamin D
Urologic Diseases

Renal Insufficiency, Chronic
Ergocalciferols
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Growth Substances
Vitamins
Physiological Effects of Drugs

Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009