CompletedPhase 1/2

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

United States17 participantsStarted 2006-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

The change in plasma phosphorus after 8 weeks of niacinamide versus placebo

Timeframe: 8 weeks

Trial details

NCT IDNCT00508885

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Hyperphosphatemia trials