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Perit Dial Int 27(Supplement_3): 12- 2007
© 2007 International Society for Peritoneal Dialysis
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Calcium, Phosphorus, PTH

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

D.O. Young, S. Cheng, J. Delmez and D. Coyne

Renal Division, Washington University, St. Louis, Missouri, USA

Objective: The purpose of this study is to determine whether niacinamide is an effective agent for the reduction of plasma phosphorus levels in patients (pts) with end-stage renal disease (ESRD) on peritoneal dialysis (PD). Hyperphosphatemia, a common problem in ESRD, can lead to renal osteodystrophy and is associated with increased morbidity and mortality in this population. Dietary modifications are rarely sufficient to attain control over plasma phosphorus levels, and current phosphate binders are limited by adverse effects or significant cost. Niacinamide, a principle form of the vitamin B complex, has been shown in animal studies to decrease phosphate uptake across the intestinal brush border membrane. One recent open-label trial found that niacinamide reduced serum phosphorus levels in hemodialysis pts; however, the study was neither randomized nor double blinded and its results have yet to be replicated. We propose an 8-week prospective, randomized, double blind, placebo-controlled trial to evaluate the efficacy of niacinamide versus placebo in the management of hyperphosphatemia in PD pts. Methods: Pts are randomized in 4x4 permutational blocks to either placebo or niacinamide treatment. Niacinamide is administered at 250 mg twice daily for the first 2 weeks, 500 mg twice daily for the next 2 weeks, and 750 mg twice daily for the final 4 weeks. Our primary end point is the change in plasma phosphorus after 8 weeks of niacinamide therapy versus placebo. Secondary end points include the change in calcium–phosphorus product, intact parathyroid hormone levels, phosphate binder usage, and lipid profiles. If there is a difference in the baseline means between the placebo and active drug study groups, percentile change in plasma phosphorus will also be compared. Results: As of 1 April 2007, we have recruited 15 of the 16 pts needed to detect a 1.5 mg/dL plasma phosphorus level difference between the 2 study groups. We anticipate being able to unblind the study results by midsummer 2007. Conclusions: Oral niacinamide may be a promising therapy to reduce plasma phosphorus levels and improve HDL cholesterol levels in PD pts.






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