| Trial ID: | L1203 |
| Source ID: | NCT00297219
|
| Associated Drug: |
Low Dialysate Calcium
|
| Title: |
Effects of Lowering Dialysate Calcium Level on Progression of Coronary Artery Calcification and Bone Histomorphometry
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End-Stage Renal Disease|Hemodialysis
|
| Interventions: |
DRUG: Low dialysate calcium|DRUG: high dialysate calcium
|
| Outcome Measures: |
Primary: Progression of coronary artery calcification scores, eighteen months|Changes in bone histomorphometry analysis, eighteen months|Changes in bone mineral density, eighteen months | Secondary: Changes in intact PTH levels, eighteen months|effects of dialysate with or without glucose (e.g intradialytic hypoglycemia and hypotension, arrythmia-by Holter ECG- and changes in HbA1c, insulin), eighteen months
|
| Sponsor/Collaborators: |
Sponsor: Ege University | Collaborators: University of Kentucky|Fresenius Medical Care North America
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
457
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2005-11
|
| Completion Date: |
2008-07
|
| Results First Posted: |
|
| Last Update Posted: |
2009-08-04
|
| Locations: |
University of Kentucky Medical Center, Lexington, Kentucky, 40536-0084, United States|FMC Clinics, Bornova, Izmir, Turkey|Ege University School of Medicine, Bornova-Izmir, 35100, Turkey
|
| URL: |
https://clinicaltrials.gov/show/NCT00297219
|
