An Open Label Trial to Evaluate the Effects of a Novel Renal Multivitamin on Inflammation and Other Biomarkers in Endstage Renal Disease Patients

Phase 2

• Conditions: Hyperphosphatemia; Inflammation; Renal Disease
• Interventions: Dietary Supplement: Oral Multivitamin

• Registration Number: NCT00834301
• Lead Sponsor: Nephrian

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Status Verified: 2009-02
• Study First Submitted: 2009-02-02
• Study First Submitted QC: 2009-02-02
• Last Update Submitted: 2009-02-02
• Study First Posted: 2009-02-03
• Last Update Posted: 2009-02-03
• Primary Completion: 2009-09
• Study Completion: 2009-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Arm	Oral Multivitamin	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
To assess the efficacy and safety of a novel renal multivitamin on markers of inflammation in an ESRD population	8 weeks

Trial Locations

Locations (1)

Simi Valley Dialysis Center; 🇺🇸 Simi Valley, California, United States