The Effect of Oral Niacinamide on Plasma Phosphorus Levels in Peritoneal Dialysis Patients

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Hyperphosphatemia is common in the peritoneal dialysis population. Current strategies are insufficient to optimize phosphorus control. Animal studies have shown niacinamide, a form of vitamin B, to reduce phosphate uptake by the rat small intestine. Our trial investigates the use of niacinamide, in addition to standard phosphorus lowering strategies, to reduce plasma phosphorus levels in peritoneal dialysis patients versus placebo.

• Phase: Phase 1/Phase 2

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Niacin; Niacinamide; Nicotinic Acids

Criteria

Inclusion Criteria:

• Age > 18 years

• Capable of giving informed consent

• Duration of peritoneal dialysis > 3 months

• Dose of phosphate binder(s) stable over previous 2 week period

• Plasma phosphours > 4.9 mg/dL based on most recent laboratory data within 1 month of enrollment

Exclusion Criteria:

• Pregnancy

• Known liver disease

• Active peptic ulcer disease

• Treatment with carbamazepine

• Intolerance to niacinamide or niacin

• Current medication regimen including niacin or niacinamide > 100 mg daily

• Planned or expected surgical procedure in the next 4 months

• Patients in nursing home or extended care facilities where administration of the study drug may not be appropriately given