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

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ClinicalTrials.gov Identifier: NCT00316472
Recruitment Status : Completed
First Posted : April 20, 2006
Last Update Posted : January 16, 2009
Sponsor:
Information provided by:

Study Description
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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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
Primary Completion Date : April 2007
Study Completion Date : December 2007

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U.S. FDA Resources

Arms and Interventions


Outcome Measures

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.

Eligibility Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT00316472


Locations
United States, Missouri
Washington University Medical Center
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Daniel W Coyne, M.D> Washington University School of Medicine
More Information

Publications:
Responsible Party: Daniel Coyne, MD, Washington University
ClinicalTrials.gov Identifier: NCT00316472     History of Changes
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:
Hyperphosphatemia
End Stage Renal Disease
Renal Osteodystrophy

Additional relevant MeSH terms:
Hyperphosphatemia
Phosphorus Metabolism Disorders
Metabolic Diseases
Niacinamide
Niacin
Nicotinic Acids
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents