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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00834301
Recruitment Status : Unknown
Verified February 2009 by Nephrian.
Recruitment status was:  Recruiting
First Posted : February 3, 2009
Last Update Posted : February 3, 2009
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Hyperphosphatemia Inflammation Renal Disease Dietary Supplement: Oral Multivitamin Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Trial to Evaluate the Effects of a Novel Renal Multivitamin on Inflammation and Other Biomarkers in Endstage Renal Disease Patients
Study Start Date : January 2009
Estimated Primary Completion Date : September 2009
Estimated Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Treatment Arm Dietary Supplement: Oral Multivitamin
Oral Multivitamin


Outcome Measures

Primary Outcome Measures :
  1. To assess the efficacy and safety of a novel renal multivitamin on markers of bone and mineral metabolism in an ESRD population. [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. To assess the efficacy and safety of a novel renal multivitamin on markers of inflammation in an ESRD population [ Time Frame: 8 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00834301


Locations
United States, California
Simi Valley Dialysis Center Recruiting
Simi Valley, California, United States, 93063
Contact: Kant Tucker, MD    805-433-7500      
Principal Investigator: Kant Tucker, MD         
Sponsors and Collaborators
Nephrian
Investigators
Study Director: Ray Chow, PhD Nephrian
More Information

Responsible Party: Ray Chow, Ph.D., Nephrian Inc
ClinicalTrials.gov Identifier: NCT00834301     History of Changes
Other Study ID Numbers: N0801
First Posted: February 3, 2009    Key Record Dates
Last Update Posted: February 3, 2009
Last Verified: February 2009

Keywords provided by Nephrian:
End Stage Renal Disease
Inflammation

Additional relevant MeSH terms:
Inflammation
Kidney Diseases
Hyperphosphatemia
Kidney Failure, Chronic
Pathologic Processes
Urologic Diseases
Phosphorus Metabolism Disorders
Metabolic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency