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

Inflammation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00834301
• Other study ID #: N0801
• Status: Recruiting
• Phase: Phase 2
• First received: February 2, 2009
• Last updated: February 2, 2009
• Start date: January 2009
• Est. completion date: September 2009

Study information

• Verified date: February 2009
• Source: Nephrian
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperphosphatemia
• Inflammation
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Disease

Intervention

Dietary Supplement:
• Oral Multivitamin
Oral Multivitamin

Locations

Country	Name	City	State
United States	Simi Valley Dialysis Center	Simi Valley	California

Sponsors (1)

Lead Sponsor	Collaborator
Nephrian

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the efficacy and safety of a novel renal multivitamin on markers of bone and mineral metabolism in an ESRD population.		8 weeks	No
Secondary	To assess the efficacy and safety of a novel renal multivitamin on markers of inflammation in an ESRD population		8 weeks	No