Clinical trial NCT00508885: The Effect of Oral Niacinamide on Plasma Phosphorus Levels in Peritoneal Dialysis Patients
Official title: The Effect of Oral Niacinamide on Plasma Phosphorus Levels in Peritoneal Dialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hyperphosphatemia
Keywords: hyperphosphatemia
niacinamide
ESRD
peritoneal dialysis
renal osteodystrophy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2007-07-30
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is a prospective, randomized, double-blind, placebo-controlled 8-week clinical trial to evaluate the efficacy of niacinamide versus placebo to reduce plasma phosphorus levels in peritoneal dialysis patients. Patients on a stable regimen of phosphate binders with plasma phosphorus levels \> 4.9 mg/dL are eligible for enrollment and randomization. The study will span 8 weeks of active medication treatment. The primary end-point will be absolute change in plasma phosphorus levels. Sixteen patients (8 randomized to each treatment arm) are needed to detect a 1.5 mg/dL difference assuming a standard deviation of 1 and powered at 80% (alpha 0.05). Placebo will be packaged to resemble the study drug in all physical attributes. The starting dose of niacinamide will be 250 mg twice daily to be titrated to 500 mg twice daily at the end of week 2 with a final titration to 750 mg twice daily at the end of week 4. Secondary end-points will include absolute change in the calcium-phosphorus product, intact parathyroid hormone, hemoglobin, platelet count, total cholesterol, HDL cholesterol, and percentage change in plasma phosphorus.

Eligibility 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

Primary outcomes:
measure: The change in plasma phosphorus after 8 weeks of niacinamide versus placebo
timeFrame: 8 weeks
Secondary outcomes:
measure: The change in intact parathyroid hormone, calcium-phosphorus product, cholesterol profile, and percentage change in plasma phosphorus
timeFrame: 8 weeks
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University, Renal Division
name: Daniel O Young, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Young DO, Cheng SC, Delmez JA, Coyne DW. The effect of oral niacinamide on plasma phosphorus levels in peritoneal dialysis patients. Perit Dial Int. 2009 Sep-Oct;29(5):562-7.