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Completed

NCT Number: NCT00772772

Vitamin D Repletion in Chronic Kidney Disease

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3

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)

Other names: Vitamin D

Primary outcomes

  1. Change in Endotoxin Activity

    Time frame: baseline and 8 weeks

    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 outcomes

  1. Blood Pressure

    Time frame: after 8 weeks of vitamin D therapy

  2. Intestinal Permeability

    Time frame: after 8 weeks of vitamin D therapy

  3. Nuclear Magnetic Resonance (NMR) Lipoprotein Profile

    Time frame: after 8 weeks of vitamin D therapy

  4. 25-hydroxy Vitamin D (25-OH Vitamin D)

    Time frame: after 8 weeks of vitamin D therapy

    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.

  5. 1, 25-OH Vitamin D

    Time frame: after 8 weeks of vitamin D therapy

Sponsors and collaborators

Lead sponsor

Rockefeller University

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 15, 2008
Registry last updated
Jan 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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