ProStat Supplementation in Dialysis Patients

Malnutrition Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00435123
• Other study ID #: 2006002
• Secondary ID: 061201 Vanderbil
• Status: Terminated
• Phase: N/A
• First received: February 12, 2007
• Last updated: February 12, 2008
• Start date: July 2007
• Est. completion date: January 2008

Study information

• Verified date: February 2008
• Source: Fresenius Medical Care North America
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

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.

Other known NCT identifiers

• NCT00458939

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• ESRD
• Malnutrition

Intervention

Dietary Supplement:
• Nutritional Supplement ProStat 64 twice a day

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

Locations

Country	Name	City	State
United States	Nephrology Associates	Columbus	Mississippi
United States	Western New England Renal Transplant Associates	Springfield	Massachusetts
United States	Metro Hypertension & Kidney Center, LLC.	St. Louis	Missouri
United States	Midwest Nephrology Associates	St. Peters	Missouri
United States	Kansas Nephrology Physicians, PA	Wichita	Kansas
United States	Lankenau Center for Medical Research	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Fresenius Medical Care North America	Medical Nutrition USA, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

Ikizler TA, Hakim RM. Nutrition in end-stage renal disease. Kidney Int. 1996 Aug;50(2):343-57. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in visceral protein stores as measured by serum albumin		3 months minimum; 6 months max	No