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Sponsored by: |
Washington University School of Medicine |
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Information provided by: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00508885 |
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.
Condition | Intervention | Phase |
---|---|---|
Hyperphosphatemia |
Drug: Niacinamide Drug: Placebo |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | The Effect of Oral Niacinamide on Plasma Phosphorus Levels in Peritoneal Dialysis Patients |
Enrollment: | 17 |
Study Start Date: | October 2006 |
Study Completion Date: | July 2007 |
Arms | Assigned Interventions |
---|---|
1: Experimental
Niacinamide starting at 250 mg twice daily titrated up to 750 mg twice daily
|
Drug: Niacinamide
Niacinamide 250 mg twice daily titrated up to 750 mg twice daily
|
2: Placebo Comparator
Placebo
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Drug: Placebo
Placebo
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
United States, Missouri | |
Washington University School of Medicine | |
St. Louis, Missouri, United States, 63110 |
Principal Investigator: | Daniel O Young, MD | Washington University, Renal Division |
Study ID Numbers: | HSC 06-0462 |
Study First Received: | July 26, 2007 |
Last Updated: | July 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00508885 |
Health Authority: | United States: Institutional Review Board |
hyperphosphatemia niacinamide ESRD peritoneal dialysis renal osteodystrophy |
Niacinamide Metabolic Diseases Renal Osteodystrophy |
Renal osteodystrophy Hyperphosphatemia Metabolic disorder |
Phosphorus Metabolism Disorders Vitamin B Complex Growth Substances Vitamins |
Physiological Effects of Drugs Micronutrients Pharmacologic Actions |