Hyperphosphatemia, Inflammation, Renal Disease
Conditions
Keywords
End Stage Renal Disease, Inflammation
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTOral Multivitamin
Oral Multivitamin
Sponsors
Nephrian
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy and safety of a novel renal multivitamin on markers of bone and mineral metabolism in an ESRD population. | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| To assess the efficacy and safety of a novel renal multivitamin on markers of inflammation in an ESRD population | 8 weeks |
Countries
United States
Outcome results
None listed