The Effect of Oral Niacinamide on Plasma Phosphorus Levels in Peritoneal Dialysis Patients
Primary Purpose
Hyperphosphatemia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Niacinamide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hyperphosphatemia focused on measuring hyperphosphatemia, niacinamide, ESRD, peritoneal dialysis, renal osteodystrophy
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years
- Capable of giving informed consent
- Duration of peritoneal dialysis > 3 months
- Dose of phosphate binder(s) stable over previous 2 week period
- Plasma phosphours > 4.9 mg/dL based on most recent laboratory data within 1 month of enrollment
Exclusion Criteria:
- Pregnancy
- Known liver disease
- Active peptic ulcer disease
- Treatment with carbamazepine
- Intolerance to niacinamide or niacin
- Current medication regimen including niacin or niacinamide > 100 mg daily
- Planned or expected surgical procedure in the next 4 months
- Patients in nursing home or extended care facilities where administration of the study drug may not be appropriately given
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Niacinamide starting at 250 mg twice daily titrated up to 750 mg twice daily
Placebo
Outcomes
Primary Outcome Measures
The change in plasma phosphorus after 8 weeks of niacinamide versus placebo
Secondary Outcome Measures
The change in intact parathyroid hormone, calcium-phosphorus product, cholesterol profile, and percentage change in plasma phosphorus
Full Information
NCT ID
NCT00508885
First Posted
July 26, 2007
Last Updated
July 26, 2007
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00508885
Brief Title
The Effect of Oral Niacinamide on Plasma Phosphorus Levels in Peritoneal Dialysis Patients
Official Title
The Effect of Oral Niacinamide on Plasma Phosphorus Levels in Peritoneal Dialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hyperphosphatemia is common in the peritoneal dialysis population. Current strategies are insufficient to optimize phosphorus control. Animal studies have shown niacinamide, a form of vitamin B, to reduce phosphate uptake by the rat small intestine. Our trial investigates the use of niacinamide, in addition to standard phosphorus lowering strategies, to reduce plasma phosphorus levels in peritoneal dialysis patients versus placebo.
Detailed Description
This is a prospective, randomized, double-blind, placebo-controlled 8-week clinical trial to evaluate the efficacy of niacinamide versus placebo to reduce plasma phosphorus levels in peritoneal dialysis patients. Patients on a stable regimen of phosphate binders with plasma phosphorus levels > 4.9 mg/dL are eligible for enrollment and randomization. The study will span 8 weeks of active medication treatment. The primary end-point will be absolute change in plasma phosphorus levels. Sixteen patients (8 randomized to each treatment arm) are needed to detect a 1.5 mg/dL difference assuming a standard deviation of 1 and powered at 80% (alpha 0.05). Placebo will be packaged to resemble the study drug in all physical attributes. The starting dose of niacinamide will be 250 mg twice daily to be titrated to 500 mg twice daily at the end of week 2 with a final titration to 750 mg twice daily at the end of week 4. Secondary end-points will include absolute change in the calcium-phosphorus product, intact parathyroid hormone, hemoglobin, platelet count, total cholesterol, HDL cholesterol, and percentage change in plasma phosphorus.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperphosphatemia
Keywords
hyperphosphatemia, niacinamide, ESRD, peritoneal dialysis, renal osteodystrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Niacinamide starting at 250 mg twice daily titrated up to 750 mg twice daily
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Niacinamide
Intervention Description
Niacinamide 250 mg twice daily titrated up to 750 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
The change in plasma phosphorus after 8 weeks of niacinamide versus placebo
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
The change in intact parathyroid hormone, calcium-phosphorus product, cholesterol profile, and percentage change in plasma phosphorus
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
Age > 18 years
Capable of giving informed consent
Duration of peritoneal dialysis > 3 months
Dose of phosphate binder(s) stable over previous 2 week period
Plasma phosphours > 4.9 mg/dL based on most recent laboratory data within 1 month of enrollment
Exclusion Criteria:
Pregnancy
Known liver disease
Active peptic ulcer disease
Treatment with carbamazepine
Intolerance to niacinamide or niacin
Current medication regimen including niacin or niacinamide > 100 mg daily
Planned or expected surgical procedure in the next 4 months
Patients in nursing home or extended care facilities where administration of the study drug may not be appropriately given
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel O Young, MD
Organizational Affiliation
Washington University, Renal Division
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19776051
Citation
Young DO, Cheng SC, Delmez JA, Coyne DW. The effect of oral niacinamide on plasma phosphorus levels in peritoneal dialysis patients. Perit Dial Int. 2009 Sep-Oct;29(5):562-7.
Results Reference
derived
Learn more about this trial
The Effect of Oral Niacinamide on Plasma Phosphorus Levels in Peritoneal Dialysis Patients
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