ProStat Supplementation in Dialysis Patients

Fresenius Medical Care (FMC)

Status: Terminated

Conditions: Malnutrition; ESRD

Treatments: Dietary Supplement: Nutritional Supplement ProStat 64 twice a day; Dietary Supplement: Placebo supplement

Study type: Interventional

Funder types: Industry

Identifiers

NCT00435123

061201 Vanderbilt IRB

2006002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups, including a placebo group

A

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Nutritional Supplement ProStat 64 twice a day

B

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo supplement