Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00056225 · ClinicalTrials.gov registry record · Phase 3

VITAL - VITamins to Slow ALzheimer's Disease (Homocysteine Study)

A Phase 3 study, sponsored by National Institute on Aging (NIA).

Completed
Registry status
Phase 3
Development phase
340
Enrollment target

NCT00056225: Completed Phase 3 study, sponsored by National Institute on Aging (NIA).

NCT00056225 is a Phase 3 study that has completed, run by National Institute on Aging (NIA). The registered enrollment target is 340 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00056225, a Phase 3 study, has completed, sponsored by National Institute on Aging (NIA).

COMPLETED
Registry status
Phase 3
Development phase
340 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether reduction of homocysteine levels with high-dose folate (folic acid), B6, and B12 supplementation will slow the rate of cognitive decline in persons with Alzheimer's disease.

Interventions

  • DRUG Vitamin B12
  • DRUG Folate
  • DRUG Vitamin B6

Trial Details

FieldValue
Enrollment Target 340 participants
Start Date 2003-01
Est. Completion 2007-06
Phase Phase 3
National Institute on Aging (NIA)

131 total trials

What the finished NCT00056225 record still lists

NCT00056225 is an interventional study that assigns participants to a tested intervention. The registered 340 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower).

The record links to 0 conditions, and to 3 interventions - of which Vitamin B12 is the first listed.

NCT00056225 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00056225 about?

NCT00056225 is a clinical study titled "VITAL - VITamins to Slow ALzheimer's Disease (Homocysteine Study)". The purpose of this study is to determine whether reduction of homocysteine levels with high-dose folate (folic acid), B6, and B12 supplementation will slow the rate of cognitive decline in persons with Alzheimer's disease.

What is the current status of trial NCT00056225?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 340 participants. The study started on 2003-01. Estimated completion is 2007-06.

What interventions are being tested in trial NCT00056225?

The interventions under investigation include: Vitamin B12 (DRUG), Folate (DRUG), Vitamin B6 (DRUG).

Who is sponsoring clinical trial NCT00056225?

This trial is sponsored by National Institute on Aging (NIA), which has 131 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00056225's enrollment target sits among peer trials

340 1053rd of 2000 higher than 945 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT04176172 · 340 participants · Phase 3

    Optimizing Tobacco Use Treatment for PLWHA

  • NCT04545424 · 340 participants · Phase 2

    Trial of Therapeutic Hypothermia in Patients With ARDS

  • NCT04806958 · 340 participants · NA

    The PulsePoint Study

  • NCT05323409 · 340 participants · NA

    Improving Comprehensive Care of Cancer Patients

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT00056225, the US trial registry maintained by the National Library of Medicine. NCT00056225 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.