Status:
COMPLETED
The Effect of Oral Niacinamide on Serum Phosphorus Levels in Hemodialysis Patients
Lead Sponsor:
Washington University School of Medicine
Conditions:
Hyperphosphatemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
Detailed Description
This is a prospective, randomized, double-blind, placebo-controlled crossover study comparing niacinamide versus placebo in the reduction of serum phosphorus in hemodialysis patients. A determination ...
Eligibility Criteria
Inclusion
- Age \> 18 years
- Capable of giving informed consent
- Duration of chronic hemodialysis \> 90 days
- Dose of phosphorus binder(s) stable over previous 2 week period
- Serum Phosphorus \> 4.9 mg/dL based on most recent laboratory data within 1 month of enrollment
Exclusion
- Pregnancy
- Known liver disease
- Active peptic ulcer disease
- Treatment with carbamazepine
- Intolerance to niacinamide
- Current medication regimen including niacin or niacinamide-containing vitamins
- More than 1 missed hemodialysis session in the last 30 days
- Planned or expected surgical procedure in the next 4 months
- Patients in nursing homes or extended care facilities where administration of the study drug may not be appropriately given
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
End Date :
December 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00316472
Start Date
April 1 2006
End Date
December 1 2007
Last Update
January 16 2009
Active Locations (1)
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1
Washington University Medical Center
St Louis, Missouri, United States, 63110