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NCT00032435 · ClinicalTrials.gov registry record · Phase 3

Homocysteine Study (HOST)

A Phase 3 study, sponsored by US Department of Veterans Affairs.

Completed
Registry status
Phase 3
Development phase
2,003
Enrollment target

NCT00032435: Completed Phase 3 study, sponsored by US Department of Veterans Affairs.

NCT00032435 is a Phase 3 study that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 2,003 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (159% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00032435, a Phase 3 study, has completed, sponsored by US Department of Veterans Affairs.

COMPLETED
Registry status
Phase 3
Development phase
2,003 participants
Enrollment target

Study Summary

The primary objective of this study is to test the hypothesis that administration of folate, pyridoxine (vitamin B6) and cyanocobalamin (vitamin B12) in high doses to patients with advanced chronic renal failure or end stage renal disease and abnormally high plasma homocysteine levels will lower the homocysteine levels and the death rate compared to patients who receive placebo. The secondary objective is to test the hypothesis that intake of the vitamins compared to placebo decreases the incidence of myocardial infarction, disabling stroke, and amputation of a lower extremity and, in hemodialysis patients, thrombosis of the vascular access.

Interventions

  • DRUG PAL-40 Active
  • DRUG PAL-40 Placebo

Trial Details

FieldValue
Enrollment Target 2,003 participants
Start Date 2001-05
Est. Completion 2006-09
Phase Phase 3
US Department of Veterans Affairs

632 total trials

What the finished NCT00032435 record still lists

NCT00032435 is an interventional study that assigns participants to a tested intervention. Its 2,003 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (159% higher).

The record links to 0 conditions, and to 2 interventions - of which PAL-40 Active is the first listed.

NCT00032435 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00032435 about?

NCT00032435 is a clinical study titled "Homocysteine Study (HOST)". The primary objective of this study is to test the hypothesis that administration of folate, pyridoxine (vitamin B6) and cyanocobalamin (vitamin B12) in high doses to patients with advanced chronic renal failure or end stage renal disease and abnormally high plasma homocysteine levels will lower the...

What is the current status of trial NCT00032435?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,003 participants. The study started on 2001-05. Estimated completion is 2006-09.

What interventions are being tested in trial NCT00032435?

The interventions under investigation include: PAL-40 Active (DRUG), PAL-40 Placebo (DRUG).

Who is sponsoring clinical trial NCT00032435?

This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00032435's enrollment target sits among peer trials

2,003 100th of 2000 higher than 1,901 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT00032435, the US trial registry maintained by the National Library of Medicine. NCT00032435 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.