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NCT02477904 · ClinicalTrials.gov registry record · NA

Ketogenic Diet Therapy for Autism Spectrum Disorder

A NA study, sponsored by Shriners Hospitals for Children.

Completed
Registry status
NA
Development phase
119
Enrollment target

NCT02477904: Completed NA study, sponsored by Shriners Hospitals for Children.

NCT02477904 is a NA study that has completed, run by Shriners Hospitals for Children. The registered enrollment target is 119 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02477904, a NA study, has completed, sponsored by Shriners Hospitals for Children.

COMPLETED
Registry status
NA
Development phase
119 participants
Enrollment target

Study Summary

This study will assess the effectiveness of the ketogenic diet (high-fat, low-carbohydrate, and moderate protein) in treating autism spectrum disorder (ASD). Three study groups will be comprised of children (2-21 years of age) based on whether or not they have ASD and receive the ketogenic diet - ASD/ketogenic diet, ASD/non-ketogenic diet, and non-ASD/non-ketogenic diet.

Primary Outcome

Assess core autistic symptoms through review/analysis of responses to the following measurement instruments: Autism Diagnostic Observation Schedule - Second Edition (ADOS-2); Asperger Syndrome Diagnostic Scale (ASDS); Childhood Autism Rating Scale (CARS-2); Gilliam Autism Rating Scale (GARS-3); Social Responsiveness Scale - Second Edition (SRS-2); Diagnostic and Statistical Manual IV Text Revision (DSM-IV-TR) and DSM-V ASD criteria; standardized intelligence tests (if available, administered by

Interventions

  • OTHER Ketogenic Diet

Trial Details

FieldValue
Enrollment Target 119 participants
Start Date 2015-03
Est. Completion 2017-04-28
Phase NA
Shriners Hospitals for Children

40 total trials

What the finished NCT02477904 record still lists

NCT02477904 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 1 intervention - of which Ketogenic Diet is the first listed.

NCT02477904 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02477904 about?

NCT02477904 is a clinical study titled "Ketogenic Diet Therapy for Autism Spectrum Disorder". This study will assess the effectiveness of the ketogenic diet (high-fat, low-carbohydrate, and moderate protein) in treating autism spectrum disorder (ASD). Three study groups will be comprised of children (2-21 years of age) based on whether or not they have ASD and receive the ketogenic diet - AS...

What is the current status of trial NCT02477904?

This trial is currently completed. It is a NA study. The enrollment target is 119 participants. The study started on 2015-03. Estimated completion is 2017-04-28.

What interventions are being tested in trial NCT02477904?

The interventions under investigation include: Ketogenic Diet (OTHER).

Who is sponsoring clinical trial NCT02477904?

This trial is sponsored by Shriners Hospitals for Children, which has 40 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02477904's enrollment target sits among peer trials

119 803rd of 2000 higher than 1,198 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 NCT02477904, the US trial registry maintained by the National Library of Medicine. NCT02477904 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.