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

Nephrian

Status and phase: Unknown; Phase 2

Conditions: Inflammation; Renal Disease; Hyperphosphatemia

Treatments: Dietary Supplement: Oral Multivitamin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00834301

N0801

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Treatment Arm

Experimental group

Treatment:

Dietary Supplement: Oral Multivitamin