The Effect of Oral Niacinamide on Serum Phosphorus Levels in Hemodialysis Patients

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Elevated phosphorus levels are a common problem in dialysis patients. However, it is associated with an increase in death and hospitalizations. Current treatment is comprised of dietary modifications and phosphorus binders - though this is often not enough for many of our patients. Our trial investigates the use of niacinamide, a form of vitamin B, in decreasing serum phosphorus levels.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Niacin; Niacinamide; Nicotinic Acids

Criteria

Inclusion Criteria:

1. Age > 18 years

2. Capable of giving informed consent

3. Duration of chronic hemodialysis > 90 days

4. Dose of phosphorus binder(s) stable over previous 2 week period

5. Serum Phosphorus > 4.9 mg/dL based on most recent laboratory data within 1 month of enrollment

Exclusion Criteria:

1. Pregnancy

2. Known liver disease

3. Active peptic ulcer disease

4. Treatment with carbamazepine

5. Intolerance to niacinamide

6. Current medication regimen including niacin or niacinamide-containing vitamins

7. More than 1 missed hemodialysis session in the last 30 days

8. Planned or expected surgical procedure in the next 4 months

9. Patients in nursing homes or extended care facilities where administration of the study drug may not be appropriately given