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

Phase 1

Completed

• Conditions: Hyperphosphatemia

• Registration Number: NCT00316472
• Lead Sponsor: Washington University School of Medicine

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 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 decrea...

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 of baseline laboratory values (serum phosphorus, calcium, albumin, biPTH, uric acid, complete blood count (CBC), and an NMR lipid panel) will precede the admini...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-04-18
• Study First Submitted QC: 2006-04-18
• Study First Posted: 2006-04-20
• Primary Completion: 2007-04
• Study Completion: 2007-12
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-14
• Last Update Posted: 2009-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Primary Endpoint: The change in serum phosphorus after 8 weeks of niacinamide versus placebo.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints: To assess the effects of niacinamide on calcium-phosphorus product, biointact parathyroid hormone levels (biPTH), and lipid profiles after 8 weeks of therapy.

Trial Locations

Locations (1)

Washington University Medical Center; 🇺🇸 Saint Louis, Missouri, United States