Status:
COMPLETED
Analysis of Calcium Balance in Chronic Kidney Disease
Lead Sponsor:
University of Colorado, Denver
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Subjects with normal kidney function are able to excrete in their urine the calcium and phosphorus absorbed via the gastrointestinal tract and are thereby are able to maintain calcium and phosphorus b...
Detailed Description
We hypothesize that by Chronic Kidney Disease (CKD) late Stage 3 and Stage 4 patients are no longer able to maintain calcium balance by excreting their daily intake of calcium. We also hypothesize tha...
Eligibility Criteria
Inclusion
- Men and women 18 years of age or greater and able to comply with the study protocol.
- eGFR within appropriate target ranges (15-40 ml/min/m² for late stage CKD stage 3 stage 4, and eGFR \> 60 ml/min/m² for normal subjects)
- Stable kidney function defined as an eGFR which remains within a 10ml/min range over a 3 to 6 month period prior to study enrollment. This will be determined from historical laboratory data.
- Willing to follow study protocol
- Have a level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel
- Overall stable medical condition, defined as no malignancy, metabolic condition or gastrointestinal condition that would make it difficult to comply with the study protocol and complete both dietary study periods
- Able to read the consent form and provide informed consent.
- Serum calcium and phosphorus within the normal range off of vitamin D analogues, calcium supplements, and phosphate binders for 1 month.
Exclusion
- 1\. Age less than 18 years
- Are pregnant, plan on becoming pregnant during the study period, or breast-feeding, if female.
- Patient declines participation.
- GI malabsorption, short bowel syndrome, frequent vomiting, or gastroparesis.
- Subject receiving synthetic parathyroid hormone, glucocorticoids, calcitonin or bisphosphonates.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00974532
Start Date
May 1 2008
End Date
February 1 2012
Last Update
December 5 2012
Active Locations (1)
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1
University of Colorado Denver Health Sciences Center
Denver, Colorado, United States, 80045