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NCT00435123 · ClinicalTrials.gov registry record · NA

ProStat Supplementation in Dialysis Patients

A NA study, sponsored by Fresenius Medical Care North America.

Terminated
Registry status
NA
Development phase
16
Enrollment target

NCT00435123: Clinical Trial NA study, sponsored by Fresenius Medical Care North America.

NCT00435123 is a NA study that was terminated before completion, run by Fresenius Medical Care North America. The registered enrollment target is 16 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00435123, a NA study, was terminated before completion, sponsored by Fresenius Medical Care North America.

TERMINATED
Registry status
NA
Development phase
16 participants
Enrollment target

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.

Interventions

  • DIETARY_SUPPLEMENT Placebo supplement
  • DIETARY_SUPPLEMENT Nutritional Supplement ProStat 64 twice a day

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2007-07
Est. Completion 2008-01
Phase NA

Why NCT00435123 stopped before completion

NCT00435123 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo supplement is the first listed.

NCT00435123 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00435123 about?

NCT00435123 is a clinical study titled "ProStat Supplementation in Dialysis Patients". 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...

What is the current status of trial NCT00435123?

This trial is currently terminated. It is a NA study. The enrollment target is 16 participants. The study started on 2007-07. Estimated completion is 2008-01.

What interventions are being tested in trial NCT00435123?

The interventions under investigation include: Placebo supplement (DIETARY_SUPPLEMENT), Nutritional Supplement ProStat 64 twice a day (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT00435123?

This trial is sponsored by Fresenius Medical Care North America, which has 13 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00435123's enrollment target sits among peer trials

16 1871st of 2000 higher than 120 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00435123, the US trial registry maintained by the National Library of Medicine. NCT00435123 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.