A randomized, double-blind, placebo-controlled trial of niacinamide for reduction of phosphorus in hemodialysis patients.
OBJECTIVE
Niacinamide inhibits intestinal sodium/phosphorus transporters and reduces serum phosphorus in open-label studies. A prospective, randomized, double-blind, placebo-controlled crossover trial was performed for assessment of the safety and efficacy of niacinamide.


METHODS
Hemodialysis patients with phosphorus levels > or =5.0 mg/dl were randomly assigned to 8 wk of niacinamide or placebo, titrated from 500 to 1500 mg/d. After a 2-wk washout period, patients switched to 8 wk of the alternative therapy. Vitamin D analogs and calcimimetics were held constant; phosphorus binders were not changed unless safety criteria were met.


RESULTS
Thirty-three patients successfully completed the trial. Serum phosphorus fell significantly from 6.26 to 5.47 mg/dl with niacinamide but not with placebo (5.85 to 5.98 mg/dl). A concurrent fall in calcium-phosphorus product was seen with niacinamide, whereas serum calcium, intact parathyroid hormone, uric acid, platelet, triglyceride, LDL, and total cholesterol levels remained stable in both arms. Serum HDL levels rose with niacinamide (50 to 61 mg/dl but not with placebo. Adverse effects were similar between both groups. Among patients who were > or =80% compliant, results were similar, although the decrease in serum phosphorus with niacinamide was more pronounced (6.45 to 5.28 mg/dl) and the increase in HDL approached significance (49 to 58 mg/dl).


CONCLUSIONS
In hemodialysis patients, niacinamide effectively reduces serum phosphorus when co-administered with binders and results in a potentially advantageous increase in HDL cholesterol. Further study in larger randomized trials and other chronic kidney disease populations is indicated.
Cheng
Steven C
SC
Division of Nephrology, Washington University School of Medicine, 660 S. Euclid Avenue, Campus Box 8129, St. Louis, MO 63110, USA. stcheng@im.wustl.edu
Young
Daniel O
DO
Huang
Yihung
Y
Delmez
James A
JA
Coyne
Daniel W
DW
D000284:Administration, Oral; D015415:Biomarkers / Q000097:blood; D002614:Chelating Agents / Q000627:therapeutic use; D018592:Cross-Over Studies; D004311:Double-Blind Method; D015536:Down-Regulation; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D054559:Hyperphosphatemia / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D007674:Kidney Diseases / Q000097:blood / Q000150:complications / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009536:Niacinamide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010758:Phosphorus / Q000097:blood*; D011446:Prospective Studies; D006435:Renal Dialysis; D050608:Sodium-Phosphate Cotransporter Proteins / Q000037:antagonists & inhibitors; D016896:Treatment Outcome; D014803:Vitamin B Complex / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D014807:Vitamin D / Q000627:therapeutic use; D014861:Washington
D015415:Biomarkers; D002614:Chelating Agents; D050608:Sodium-Phosphate Cotransporter Proteins; D014803:Vitamin B Complex; D014807:Vitamin D; D009536:Niacinamide; D010758:Phosphorus