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NCT00090428 · ClinicalTrials.gov registry record · Phase 1

Diet and Behavior in Young Children With Autism

A Phase 1 study, sponsored by University of Rochester.

Completed
Registry status
Phase 1
Development phase
21
Enrollment target

NCT00090428: Completed Phase 1 study, sponsored by University of Rochester.

NCT00090428 is a Phase 1 study that has completed, run by University of Rochester. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00090428, a Phase 1 study, has completed, sponsored by University of Rochester.

COMPLETED
Registry status
Phase 1
Development phase
21 participants
Enrollment target

Study Summary

This study will determine whether a gluten- and casein-free diet has specific benefits for children with autism.

Primary Outcome

Behavioral data: activity, sleep, behaviors related to the autism; Medical data: stool pattern, nutrition

Interventions

  • BEHAVIORAL Gluten- and casein-free diet
  • BEHAVIORAL Placebo controlled diet

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2004-01
Est. Completion 2009-02
Phase Phase 1
University of Rochester

636 total trials

What the finished NCT00090428 record still lists

NCT00090428 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).

The record links to 0 conditions, and to 2 interventions - of which Gluten- and casein-free diet is the first listed.

NCT00090428 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00090428 about?

NCT00090428 is a clinical study titled "Diet and Behavior in Young Children With Autism". This study will determine whether a gluten- and casein-free diet has specific benefits for children with autism.

What is the current status of trial NCT00090428?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2004-01. Estimated completion is 2009-02.

What interventions are being tested in trial NCT00090428?

The interventions under investigation include: Gluten- and casein-free diet (BEHAVIORAL), Placebo controlled diet (BEHAVIORAL).

Who is sponsoring clinical trial NCT00090428?

This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00090428's enrollment target sits among peer trials

21 1615th of 2000 higher than 372 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT00090428, the US trial registry maintained by the National Library of Medicine. NCT00090428 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.