Vitamin D Repletion in Chronic Kidney Disease

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Drug: Vitamin D3

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Early Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); Other Names: Vitamin D

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure		after 8 weeks of vitamin D therapy
Intestinal Permeability		after 8 weeks of vitamin D therapy
Nuclear Magnetic Resonance (NMR) Lipoprotein Profile		after 8 weeks of vitamin D therapy
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
1, 25-OH Vitamin D		after 8 weeks of vitamin D therapy

Collaborators and Investigators

• Sponsor: Rockefeller University
• Investigators: Principal Investigator: Manish Ponda, MD, Rockefeller University

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: October 13, 2008
• First Submitted That Met QC Criteria: October 13, 2008
• First Posted (Estimate): October 15, 2008

Study Record Updates

• Last Update Posted (Estimate): January 15, 2015
• Last Update Submitted That Met QC Criteria: January 6, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: intestinal permeability; Vitamin D3 repletion; levels of endotoxin; accelerated atherosclerosis
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: MAP-0626