| ID | Type | Description | Link |
|---|---|---|---|
| 061201 Vanderbilt IRB |
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Increased use of commercial product; less eligible patients & poor enrollment.
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| Name | Class |
|---|---|
| Medical Nutrition USA, Inc. | INDUSTRY |
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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.
Fifty patients identified as having poor nutrition by the following criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional Supplement ProStat 64 twice a day | Dietary Supplement |
| ||
| Placebo supplement |
| Measure | Description | Time Frame |
|---|---|---|
| Increase in visceral protein stores as measured by serum albumin | 3 months minimum; 6 months max |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Kaplan, M.D. | Fresenius Medical Care North America | Principal Investigator |
| Alp Ikizler, M.D. | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kansas Nephrology Physicians, PA | Wichita | Kansas | 67214 | United States | ||
| Western New England Renal Transplant Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10231458 | Background | Ikizler TA, Wingard RL, Harvell J, Shyr Y, Hakim RM. Association of morbidity with markers of nutrition and inflammation in chronic hemodialysis patients: a prospective study. Kidney Int. 1999 May;55(5):1945-51. doi: 10.1046/j.1523-1755.1999.00410.x. | |
| 8840260 | Background | Ikizler TA, Hakim RM. Nutrition in end-stage renal disease. Kidney Int. 1996 Aug;50(2):343-57. doi: 10.1038/ki.1996.323. |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
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| Dietary Supplement |
Patients randomly assigned to Placebo for the first 3 months will receive open label Prostat for the last 3 months |
|
| Springfield |
| Massachusetts |
| 01107 |
| United States |
| Nephrology Associates | Columbus | Mississippi | 39705 | United States |
| Midwest Nephrology Associates | City of Saint Peters | Missouri | 63376 | United States |
| Metro Hypertension & Kidney Center, LLC. | St Louis | Missouri | 63136 | United States |
| Lankenau Center for Medical Research | Wynnewood | Pennsylvania | 19096 | United States |
| 12164890 | Background | Caglar K, Fedje L, Dimmitt R, Hakim RM, Shyr Y, Ikizler TA. Therapeutic effects of oral nutritional supplementation during hemodialysis. Kidney Int. 2002 Sep;62(3):1054-9. doi: 10.1046/j.1523-1755.2002.00530.x. |
| 12189242 | Background | Pupim LB, Flakoll PJ, Brouillette JR, Levenhagen DK, Hakim RM, Ikizler TA. Intradialytic parenteral nutrition improves protein and energy homeostasis in chronic hemodialysis patients. J Clin Invest. 2002 Aug;110(4):483-92. doi: 10.1172/JCI15449. |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |