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

This study has been completed.
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00508885
First received: July 26, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Effect of Oral Niacinamide on Plasma Phosphorus Levels in Peritoneal Dialysis Patients

Resource links provided by NLM:


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
Experimental: 1
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
Placebo Comparator: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by Washington University School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00508885     History of Changes
Other Study ID Numbers: HSC 06-0462
Study First Received: July 26, 2007
Last Updated: July 26, 2007
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Hyperphosphatemia
Phosphorus Metabolism Disorders
Metabolic Diseases
Niacinamide
Niacin
Nicotinic Acids
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents

ClinicalTrials.gov processed this record on July 23, 2014