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

NCT ID: NCT00508885

Last Updated: 2007-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2007-07-31

Brief 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.

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.

Conditions

Hyperphosphatemia

Keywords

hyperphosphatemia; niacinamide; ESRD; peritoneal dialysis; renal osteodystrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Niacinamide starting at 250 mg twice daily titrated up to 750 mg twice daily

Group Type: EXPERIMENTAL

Niacinamide

Intervention Type: DRUG

Niacinamide 250 mg twice daily titrated up to 750 mg twice daily

2

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Niacinamide

Niacinamide 250 mg twice daily titrated up to 750 mg twice daily

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Principal Investigators

Daniel O Young, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University, Renal Division

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

References

Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

Reference Type: DERIVED

PMID: 40576086 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 19776051 (View on PubMed)

Other Identifiers

HSC 06-0462

Identifier Type: -

Identifier Source: org_study_id