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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hyperphosphatemia Inflammation Renal Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Arm

Group Type EXPERIMENTAL

Oral Multivitamin

Intervention Type DIETARY_SUPPLEMENT

Oral Multivitamin

Interventions

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Oral Multivitamin

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No