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ScanBrit Dietary Intervention in Autism

NCT00614198 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2010-10-01

Study results available
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Summary

A growing body of research indicates that dietary intervention excluding foods containing the proteins, gluten and casein, from the diet of children diagnosed with an autism spectrum disorder (ASD) may have a positive effect on behaviour and developmental outcome.

In this single-blind, randomised-controlled, matched-pair adaptive trial, we introduced a gluten- and casein-free (GFCF) diet to a group of pre-pubescent children diagnosed with ASD concurrently with an abnormal urinary profile. Following random allocation to a diet or non- diet group, stage 1 of the study saw an intervention group follow the GFCF diet for eight months initially - progressing to 12 months if required. A non-diet control group continued with a normal diet.

Assuming significant changes for the dietary group on the various outcome measures of behaviour and development, stage 2 of the study saw both groups assigned to GFCF dietary intervention for a further 12 months when outcome measures were again assessed at study end.

Conditions

  • Autism
  • Autism Spectrum Disorder (ASD)

Interventions

OTHER

Gluten- and casein-free diet

Removal of foods containing gluten (cereal produce) and casein (dairy produce)

Sponsors & Collaborators

  • Norway: Bo Nils og Seim Family Settlement

    collaborator UNKNOWN

  • The Robert Luff Foundation, United Kingdom

    collaborator UNKNOWN

  • Eric Birger Christensen Fond, Denmark

    collaborator UNKNOWN

  • Norsk Proteinintolerance, Norway

    collaborator UNKNOWN

  • Center for Autisme, Denmark

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2008-10-31
Completion
2008-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00614198 on ClinicalTrials.gov