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ProStat Supplementation in Dialysis Patients

NCT00435123 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2008-02-21

No results posted yet for this study

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.

Conditions

  • Malnutrition
  • ESRD

Interventions

DIETARY_SUPPLEMENT

Nutritional Supplement ProStat 64 twice a day

DIETARY_SUPPLEMENT

Placebo supplement

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

Sponsors & Collaborators

  • Medical Nutrition USA, Inc.

    collaborator INDUSTRY

  • Fresenius Medical Care North America

    lead INDUSTRY

Principal Investigators

  • Mark Kaplan, M.D. · Fresenius Medical Care North America

  • Alp Ikizler, M.D. · Vanderbilt University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2008-01-31
Completion
2008-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00435123 on ClinicalTrials.gov