Status:
COMPLETED
Vitamin D Repletion in Chronic Kidney Disease
Lead Sponsor:
Rockefeller University
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
50-80 years
Phase:
EARLY_PHASE1
Brief 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 mad...
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 * Ta...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00772772
Start Date
March 1 2008
End Date
October 1 2009
Last Update
January 15 2015
Active Locations (1)
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1
Rockefeller University
New York, New York, United States, 10065