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

Hyperphosphatemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00508885
• Other study ID #: HSC 06-0462
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 26, 2007
• Last updated: July 26, 2007
• Start date: October 2006
• Est. completion date: July 2007

Study information

• Verified date: July 2007
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 2007
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperphosphatemia

Intervention

Drug:
• Niacinamide
Niacinamide 250 mg twice daily titrated up to 750 mg twice daily
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in plasma phosphorus after 8 weeks of niacinamide versus placebo		8 weeks
Secondary	The change in intact parathyroid hormone, calcium-phosphorus product, cholesterol profile, and percentage change in plasma phosphorus		8 weeks