An Open Label Trial to Evaluate the Effects of a Novel Renal Multivitamin on Inflammation and Other Biomarkers in Endstage Renal Disease Patients
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/2/2016 |
| Start Date: | January 2009 |
| End Date: | September 2009 |
The purpose of the study is to determine whether an ingestion of a new renal multivitamin
supplement can have a beneficial effect on bone and mineral adn inflammation issues related
to patients on dialysis.
supplement can have a beneficial effect on bone and mineral adn inflammation issues related
to patients on dialysis.
Inclusion Criteria:
- End stage renal disease patients on dialysis for at least 90 days deemed to be at low
risk by the investigator for being hospitalized or have concurrent infections
- Serum phosphorous level > 5 mg/dl
- Stable phosphate binder regimen for 2 week prior to enrollment
- Stable dose of Vitamin D for 4 weeks prior to enrollment
- Stable calcimimetic dose for 4 week prior to enrollment
Exclusion Criteria:
- patients who are pregnant
- patients who have pre existing thrombocytopenia defined as a platelet count of <100 x
109/L
- abnormal LFTs
- baseline CRP > 15 g/dl
- known sensitivity to any of the active ingredients
- patients who are currently enrolled in a clinical trial, or who have been in a
clinical trial in the last six months
- are currently taking any immunosuppressive medications
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