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| Sponsor: | Fresenius Medical Care North America |
|---|---|
| Collaborator: |
Medical Nutrition USA, Inc. |
| Information provided by: | Fresenius Medical Care North America |
| ClinicalTrials.gov Identifier: | NCT00435123 |
Purpose
This is a long-term, randomized, placebo-controlled, double blind clinical study of a nutritional supplement, ProStat 64, in chronic hemodialysis patients with poor nutrition. Subjects receive either ProStat 64 or Placebo for three months. At the end of this period, all subjects will receive ProStat-64 for a further 3 months at which time the study is ended. Parameters of nutritional status (lean body mass and serum protein) will be collected at baseline, 3 months and 6 months.
| Condition | Intervention |
|---|---|
|
Malnutrition ESRD |
Dietary Supplement: Nutritional Supplement ProStat 64 twice a day Dietary Supplement: Placebo supplement |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
| Official Title: | A Randomized, Placebo Controlled, Double Blind Study of the Use of a Nutritional Supplement, ProStat-64, in Chronic Hemodialysis Patients With Poor Nutritional Status. |
| Enrollment: | 16 |
| Study Start Date: | July 2007 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Active Comparator
Patients are randomly assigned to receive either Active Comparator (ProStat 64) or placebo for the first 3 months. At the end of this, all patients receive open label ProStat64.
|
Dietary Supplement: Nutritional Supplement ProStat 64 twice a day |
|
B: Placebo Comparator
Patients are randomly assigned to Placebo Comparator or Active Comparator (ProStat 64). At the end of 3 months, all patients receive active ProStat 64
|
Dietary Supplement: Placebo supplement
Patients randomly assigned to Placebo for the first 3 months will receive open label Prostat for the last 3 months
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Fifty patients identified as having poor nutrition by the following criteria:
one of the four following criteria:
Biochemical parameters of malnutrition defined by 1 of 2 of the following measurements (if available) over the consecutive two months prior to inclusion:
will be randomized to receive either ProStat 64 or placebo for 3 months. At Baseline a Dexa for lean body mass and labs for BUN, creatinine, glucose, serum albumin, prealbumin and C-reactive protein will be drawn. Cholesterol and transferrin will be recorded from the regular monthly labs if available. In addition, a protein catabolic rate will be calculated and a SGA will be completed.
Patients will take the supplement/placebo twice a day. Measurements will be repeated at month 3. At the end of these measurements, all patients will be switched to open label ProStat64 for an additional 3 months. At month 6 all study procedures/labs are repeated and the study is complete.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Sub-optimal nutritional status identified by one of the four following criteria:
Biochemical parameters of malnutrition defined by 1 of 2 of the following measurements (if available) over the consecutive two months prior to inclusion:
Exclusion Criteria:
Contacts and Locations| United States, Kansas | |
| Kansas Nephrology Physicians, PA | |
| Wichita, Kansas, United States, 67214 | |
| United States, Massachusetts | |
| Western New England Renal Transplant Associates | |
| Springfield, Massachusetts, United States, 01107 | |
| United States, Mississippi | |
| Nephrology Associates | |
| Columbus, Mississippi, United States, 39705 | |
| United States, Missouri | |
| Metro Hypertension & Kidney Center, LLC. | |
| St. Louis, Missouri, United States, 63136 | |
| Midwest Nephrology Associates | |
| St. Peters, Missouri, United States, 63376 | |
| United States, Pennsylvania | |
| Lankenau Center for Medical Research | |
| Wynnewood, Pennsylvania, United States, 19096 | |
| Principal Investigator: | Mark Kaplan, M.D. | Fresenius Medical Care North America |
| Principal Investigator: | Alp Ikizler, M.D. | Vanderbilt University |
More Information
| Responsible Party: | Fresenius Medical Care North America ( Mark Kaplan, M.D., Vice-President Research ) |
| Study ID Numbers: | 2006002, 061201 Vanderbilt IRB |
| Study First Received: | February 12, 2007 |
| Last Updated: | February 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00435123 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Malnutrition ESRD Hemodialysis |
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Malnutrition Nutrition Disorders |