title: Effect of chitosan chewing gum on reducing serum phosphorus in hemodialysis patients: a multi-center, randomized, double-blind, placebo-controlled trial.
abstract: BACKGROUND
  HS219 (40 mg chitosan-loaded chewing gum) is designed to bind salivary phosphorus as an add-on to available phosphorus binders. We performed a randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of HS219 in hemodialysis (HD) patients with hyperphosphatemia as an add-on to phosphorus binders.
  
  
  METHODS
  Sixty-eight HD patients who were maintained on calcium carbonate (n=33) or sevelamer hydrochloride (n=35) were enrolled. The primary end point was a change in serum phosphorus levels. Secondary end points included changes in levels of salivary phosphorus, serum calcium, parathyroid hormone (PTH), and intact fibroblast growth factor (iFGF) 23.
  
  
  RESULTS
  Sixty-three patients chewed either HS219 (n=35) or placebo (n=28) for 30 min, three times a day, for 3 weeks. HS219 was well tolerated and safe. However, HS219 was not superior to placebo with additional reduction of serum phosphorus with respect to phosphorus binders at the end of the chewing period. There were no significant effects of HS219 on reduction of salivary phosphorus, serum calcium, iPTH, or iFGF23 levels.
  
  
  CONCLUSIONS
  The chitosan-loaded chewing gum HS219 does not affect serum and salivary phosphorus levels in Japanese HD patients with hyperphosphatemia. Our findings do not support previous findings that 20 mg of chitosan-loaded chewing gum reduces serum and salivary phosphorus levels.
  
  
  BACKGROUND
  [corrected] ClinicalTrials.gov NCT01039428, 24 December, 2009.
authors: Showa University School of Medicine, Tokyo, Japan. akizawa@med.showa-u.ac.jp.
authors: Tadao
authors: T
authors: Akizawa
authors: Yoshinari
authors: Y
authors: Tsuruta
authors: Yoichi
authors: Y
authors: Okada
authors: Yoshihiro
authors: Y
authors: Miyauchi
authors: Akio
authors: A
authors: Suda
authors: Hiroshi
authors: H
authors: Kasahara
authors: Nobuhiro
authors: N
authors: Sasaki
authors: Yoshitaka
authors: Y
authors: Maeda
authors: Takako
authors: T
authors: Suzuki
authors: Noriaki
authors: N
authors: Matsui
authors: Jun
authors: J
authors: Niwayama
authors: Toshiaki
authors: T
authors: Suzuki
authors: Hideaki
authors: H
authors: Hara
authors: Yasushi
authors: Y
authors: Asano
authors: Sadao
authors: S
authors: Komemushi
authors: Masafumi
authors: M
authors: Fukagawa
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D002638:Chewing Gum; D048271:Chitosan / Q000008:administration & dosage*; D003692:Delayed-Action Preparations / Q000008:administration & dosage; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D054559:Hyperphosphatemia / Q000097:blood* / Q000209:etiology / Q000517:prevention & control*; D007676:Kidney Failure, Chronic / Q000097:blood / Q000150:complications / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010758:Phosphorus / Q000097:blood*; D015990:Placebo Effect; D006435:Renal Dialysis / Q000009:adverse effects*; D016896:Treatment Outcome
chemical_list: D002638:Chewing Gum; D003692:Delayed-Action Preparations; D010758:Phosphorus; D048271:Chitosan