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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00508885
First Posted: July 30, 2007
Last Update Posted: July 30, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Washington University School of Medicine
July 26, 2007
July 30, 2007
July 30, 2007
October 2006
Not Provided
The change in plasma phosphorus after 8 weeks of niacinamide versus placebo [ Time Frame: 8 weeks ]
Same as current
No Changes Posted
The change in intact parathyroid hormone, calcium-phosphorus product, cholesterol profile, and percentage change in plasma phosphorus [ Time Frame: 8 weeks ]
Same as current
Not Provided
Not Provided
 
The Effect of Oral Niacinamide on Plasma Phosphorus Levels in Peritoneal Dialysis Patients
The Effect of Oral Niacinamide on Plasma Phosphorus Levels in Peritoneal Dialysis Patients
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.
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.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Hyperphosphatemia
  • Drug: Niacinamide
    Niacinamide 250 mg twice daily titrated up to 750 mg twice daily
  • Drug: Placebo
    Placebo
  • Experimental: 1
    Niacinamide starting at 250 mg twice daily titrated up to 750 mg twice daily
    Intervention: Drug: Niacinamide
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
July 2007
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00508885
HSC 06-0462
No
Not Provided
Not Provided
Not Provided
Washington University School of Medicine
Not Provided
Principal Investigator: Daniel O Young, MD Washington University, Renal Division
Washington University School of Medicine
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP