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The Effect of Oral Niacinamide on Plasma Phosphorus Levels in Peritoneal Dialysis Patients
This study has been completed.
Sponsored by: Washington University School of Medicine
Information provided by: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00508885
  Purpose

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.


Condition Intervention Phase
Hyperphosphatemia
Drug: Niacinamide
Drug: Placebo
Phase I
Phase II

MedlinePlus related topics: Kidney Failure
Drug Information available for: Phosphorus Niacinamide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: The Effect of Oral Niacinamide on Plasma Phosphorus Levels in Peritoneal Dialysis Patients

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • The change in plasma phosphorus after 8 weeks of niacinamide versus placebo [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • The change in intact parathyroid hormone, calcium-phosphorus product, cholesterol profile, and percentage change in plasma phosphorus [ Time Frame: 8 weeks ]

Enrollment: 17
Study Start Date: October 2006
Study Completion Date: July 2007
Arms Assigned Interventions
1: Experimental
Niacinamide starting at 250 mg twice daily titrated up to 750 mg twice daily
Drug: Niacinamide
Niacinamide 250 mg twice daily titrated up to 750 mg twice daily
2: Placebo Comparator
Placebo
Drug: Placebo
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00508885

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Daniel O Young, MD Washington University, Renal Division
  More Information

Study ID Numbers: HSC 06-0462
Study First Received: July 26, 2007
Last Updated: July 26, 2007
ClinicalTrials.gov Identifier: NCT00508885  
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
hyperphosphatemia
niacinamide
ESRD
peritoneal dialysis
renal osteodystrophy

Study placed in the following topic categories:
Niacinamide
Metabolic Diseases
Renal Osteodystrophy
Renal osteodystrophy
Hyperphosphatemia
Metabolic disorder

Additional relevant MeSH terms:
Phosphorus Metabolism Disorders
Vitamin B Complex
Growth Substances
Vitamins
Physiological Effects of Drugs
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009