Early Phase 1
Completed N=12
Vitamin D Repletion in Chronic Kidney Disease
Chronic Kidney Disease
Source: ClinicalTrials.gov NCT00772772 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jun 2011
Primary outcomePrimary: Change in Endotoxin Activity — -.057 EA units
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Endotoxin Activity |
-.057 | — |
| SECONDARY Blood Pressure |
— | — |
| SECONDARY Intestinal Permeability |
— | — |
| SECONDARY Nuclear Magnetic Resonance (NMR) Lipoprotein Profile |
— | — |
| SECONDARY 25-hydroxy Vitamin D (25-OH Vitamin D) |
37.4 | — |
| SECONDARY 1, 25-OH Vitamin D |
— | — |
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT00772772). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.