Vitamin D Repletion in Chronic Kidney Disease - Full Text View

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. Normal subjects are enrolled to have a 'control' set for comparison purposes.

Condition	Intervention	Phase
Chronic Kidney Disease	Drug: Vitamin D3	Phase 0

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Effect of Vitamin D3 Repletion in Chronic Kidney Disease Stage 3

Resource links provided by NLM:

MedlinePlus related topics: Chronic Kidney Disease Vitamin D

Drug Information available for: Cholecalciferol Vitamin D

U.S. FDA Resources

Further study details as provided by Rockefeller University:

Primary Outcome Measures:

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).

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 ]
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 ]

Enrollment:	12
Study Start Date:	March 2008
Study Completion Date:	October 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Vitamin D3 Vitamin D3 30,000 international units orally per week for 8 weeks	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:	Yes

Criteria

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

Contacts and Locations

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

Locations

United States, New York
Rockefeller University
New York, New York, United States, 10065

Sponsors and Collaborators

Rockefeller University

Investigators

Principal Investigator:

Manish Ponda, MD

Rockefeller University

More Information

No publications provided

Responsible Party:	Manish Ponda, MD, Rockefeller University
ClinicalTrials.gov Identifier:	NCT00772772 History of Changes
Other Study ID Numbers:	MAP-0626
Study First Received:	October 13, 2008
Results First Received:	March 10, 2011
Last Updated:	May 11, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Rockefeller University:

Vitamin D3 repletion
levels of endotoxin
intestinal permeability
accelerated atherosclerosis

Additional relevant MeSH terms:

Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Cholecalciferol
Vitamin D

Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 16, 2013