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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Hyperphosphatemia

In brief

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.

Key facts

Study ID

NCT00508885

Run by

Washington University School of Medicine

People needed

17

Starts

2006-10-01

Expected to finish

2007-07-01

Last updated by the study team

2007-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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