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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00316472
Recruitment Status : Completed
First Posted : April 20, 2006
Last Update Posted : January 16, 2009
Information provided by:
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 decreasing serum phosphorus levels.

Condition or disease Intervention/treatment Phase
Hyperphosphatemia Drug: Niacinamide Phase 1

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 administration of the study drugs. The study will span a period of 21 weeks during which phosphorus levels will be checked on a weekly basis. Phosphorus binder dose will remain unchanged unless for safety reasons. For the first 8 weeks of treatment, patients will be randomized to either placebo or niacinamide. Both medications will be administered with a starting dose of one capsule twice per day (BID). Niacinamide and placebo will be formulated in 250 mg capsules. Placebo will be packaged to resemble the study drug in all physical attributes. The dose of niacinamide or placebo will be increased to 500 mg (2 capsules) BID at week 3 and 750 mg (3 capsules) BID at week 5. If hypophosphatemia (< 3.5 mg/dl) is present, then titration will not occur and the previous dose will be continued. However, titration will resume in subsequent weeks if the serum phosphorus is greater than 3.5 mg/dl. After 8 weeks, patients will undergo a 2 week washout period, then crossover from treatment arm to placebo, or vice versa, at week 11.

At the beginning of week 11, patients will cross over to the other treatment arm (either placebo or niacinamide) at one capsule (250 mg) twice per day. Subsequent titration will occur at week 13 and week 15. The treatment phase will be completed at the end of week 18. A set of labs will be drawn at the start of week 19, followed by a two week washout period.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Effect of Oral Niacinamide on Serum Phosphorus Levels in Hemodialysis Patients
Study Start Date : April 2006
Actual Primary Completion Date : April 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Primary Endpoint: The change in serum phosphorus after 8 weeks of niacinamide versus placebo.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00316472

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United States, Missouri
Washington University Medical Center
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
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Principal Investigator: Daniel W Coyne, M.D> Washington University School of Medicine
Publications of Results:
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Responsible Party: Daniel Coyne, MD, Washington University Identifier: NCT00316472    
Other Study ID Numbers: HSC05-0958
First Posted: April 20, 2006    Key Record Dates
Last Update Posted: January 16, 2009
Last Verified: January 2009
Keywords provided by Washington University School of Medicine:
End Stage Renal Disease
Renal Osteodystrophy
Additional relevant MeSH terms:
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Phosphorus Metabolism Disorders
Metabolic Diseases
Nicotinic Acids
Vitamin B Complex
Physiological Effects of Drugs
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents