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

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.

Study Overview

• Status: Unknown
• Conditions: Inflammation; Hyperphosphatemia; Renal Disease
• Intervention / Treatment: Dietary supplement: Oral Multivitamin

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Simi Valley, California, United States, 93063
      • Recruiting
      • Simi Valley Dialysis Center
      • Contact: Kant Tucker, MD; Phone Number: 805-433-7500
      • Principal Investigator: Kant Tucker, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm	Dietary supplement: Oral Multivitamin; Oral Multivitamin

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nephrian
• Investigators: Study Director: Ray Chow, PhD, Nephrian

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Anticipated): September 1, 2009
• Study Completion (Anticipated): September 1, 2009

Study Registration Dates

• First Submitted: February 2, 2009
• First Submitted That Met QC Criteria: February 2, 2009
• First Posted (Estimate): February 3, 2009

Study Record Updates

• Last Update Posted (Estimate): February 3, 2009
• Last Update Submitted That Met QC Criteria: February 2, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: Inflammation; End Stage Renal Disease
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Phosphorus Metabolism Disorders; Kidney Diseases; Inflammation; Kidney Failure, Chronic; Hyperphosphatemia
• Other Study ID Numbers: N0801