ProStat Supplementation in Dialysis Patients

NCT ID: NCT00435123

Last Updated: 2008-02-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2008-01-31

Brief Summary

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.

Detailed Description

Fifty patients identified as having poor nutrition by the following criteria:

1. Average of Serum Albumin for the consecutive two months prior to inclusion </= 3.7 g/dl and the serum albumin for the previous month is < 3.7 mg/dl.

2. one of the four following criteria:

1. Protein catabolic rate less than 1.0 g/kg/d on at least 2 occasions over the past 6 months

2. Progressive unintentional weight loss more than 2.5% of the initial or ideal body weight and/or patients who are less than 90% of Standard Body Weight

3. Subjective Global Assessment Score consistent with Moderate to Severe Malnutrition within the last month

4. Biochemical parameters of malnutrition defined by 1 of 2 of the following measurements (if available) over the consecutive two months prior to inclusion:

1. Serum transferrin concentration less than 225 mg/dl

2. Serum prealbumin concentration less than 32 mg/dl

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.

Conditions

Malnutrition; ESRD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

A

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.

Group Type: ACTIVE_COMPARATOR

Nutritional Supplement ProStat 64 twice a day

Intervention Type: DIETARY_SUPPLEMENT

B

Patients are randomly assigned to Placebo Comparator or Active Comparator (ProStat 64). At the end of 3 months, all patients receive active ProStat 64

Group Type: PLACEBO_COMPARATOR

Placebo supplement

Intervention Type: DIETARY_SUPPLEMENT

Patients randomly assigned to Placebo for the first 3 months will receive open label Prostat for the last 3 months

Interventions

Nutritional Supplement ProStat 64 twice a day

Intervention Type: DIETARY_SUPPLEMENT

Placebo supplement

Patients randomly assigned to Placebo for the first 3 months will receive open label Prostat for the last 3 months

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• On hemodialysis
• Optimally dialyzed with a biocompatible membrane (URR > 70% and/or delivered Kt/V >1.2)
• Patient or next of kin able to sign consent form
• Average of Serum Albumin for the consecutive two months prior to inclusion </= 3.7 g/dl and the serum albumin for the previous month is < 3.7 mg/dl.
• Sub-optimal nutritional status identified by one of the four following criteria:

1. Protein catabolic rate less than 1.0 g/kg/d on at least 2 occasions over the past 6 months

2. Progressive unintentional weight loss more than 2.5% of the initial or ideal body weight and/or patients who are less than 90% of Standard Body Weight

3. Subjective Global Assessment Score consistent with Moderate to Severe Malnutrition within the last month

4. Biochemical parameters of malnutrition defined by 1 of 2 of the following measurements (if available) over the consecutive two months prior to inclusion:

1. Serum transferrin concentration less than 225 mg/dl

2. Serum prealbumin concentration less than 32 mg/dl

• Patient is able to transfer with minimal or no assistance.
• Not taking a caloric nutritional supplement for the last 30 days (e.g. Nepro, ProStat, Boost,etc).

Exclusion Criteria

• Active auto-immune, inflammatory or infectious disease
• Documented malignancy within the last 12 months
• Patients on unusual dietary restrictions
• Life-expectancy less than 6 months
• Inability to tolerate nutritional supplements
• Patient does not exceed the DEXA machine weight limit.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical Nutrition USA, Inc.

INDUSTRY

Sponsor Role: collaborator

Fresenius Medical Care North America

INDUSTRY

Sponsor Role: lead

Responsible Party

Fresenius Medical Care North America

Principal Investigators

Mark Kaplan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Fresenius Medical Care North America

Alp Ikizler, M.D.

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

Kansas Nephrology Physicians, PA

Wichita, Kansas, United States

Western New England Renal Transplant Associates

Springfield, Massachusetts, United States

Nephrology Associates

Columbus, Mississippi, United States

Midwest Nephrology Associates

City of Saint Peters, Missouri, United States

Metro Hypertension & Kidney Center, LLC.

St Louis, Missouri, United States

Lankenau Center for Medical Research

Wynnewood, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 10231458 (View on PubMed)

Ikizler TA, Hakim RM. Nutrition in end-stage renal disease. Kidney Int. 1996 Aug;50(2):343-57. doi: 10.1038/ki.1996.323.

Reference Type: BACKGROUND

PMID: 8840260 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12164890 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12189242 (View on PubMed)

Other Identifiers

061201 Vanderbilt IRB

Identifier Type: -

Identifier Source: secondary_id

2006002

Identifier Type: -

Identifier Source: org_study_id

NCT00458939

Identifier Type: -

Identifier Source: nct_alias