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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Nephrian.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Nephrian
ClinicalTrials.gov Identifier:
NCT00834301
First received: February 2, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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 Intervention Phase
Hyperphosphatemia
Inflammation
Renal Disease
Dietary Supplement: Oral Multivitamin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Nephrian:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the efficacy and safety of a novel renal multivitamin on markers of inflammation in an ESRD population [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: January 2009
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm Dietary Supplement: Oral Multivitamin
Oral Multivitamin

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ray Chow, Ph.D., Nephrian Inc
ClinicalTrials.gov Identifier: NCT00834301     History of Changes
Other Study ID Numbers: N0801
Study First Received: February 2, 2009
Last Updated: February 2, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Nephrian:
End Stage Renal Disease
Inflammation

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

ClinicalTrials.gov processed this record on August 21, 2014