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ISRCTN
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ISRCTN18725918
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ClinicalTrials.gov identifier
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NCT01197131
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Public title
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Urinary Steroid Metabolites in Autism
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Scientific title
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Urinary Steroid Metabolites in Autism: An observational trial of 4 parallel groups
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Acronym
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USMiA
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Serial number at source
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1.0
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Study hypothesis
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Widespread alteration of gene activation is contributed to alteration in hormone formation with elevated androgens in autism spectrum disorder
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Lay summary
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Ethics approval
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The government ethics committee approved on the 12th of August 2010 (ref: FA8B-50.2-98/2010-4 )
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Study design
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Single centre observational 4 arm parallel group cohort trial
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Countries of recruitment
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Austria
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Disease/condition/study domain
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Autism spectrum disorder, urinary steroid hormone metabolites
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Participants - inclusion criteria
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1. Age between 5 and 15 years
2. Autism spectrum disorder ascertained by clinical investigation by an experienced paediatrician or Autism Diagnostic Interview - Revised (ADI-R) / Autism Diagnostic Observation Schedule (ADOS)
3. Healthy controls comparable in gender, age, weight and length to autistic participants
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Participants - exclusion criteria
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1. Epilepsy
2. Other severe illness
3. Pregnancy
4. Psychotropic medication
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Anticipated start date
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10/08/2010
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Anticipated end date
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30/06/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use contact details below to request a patient information sheet
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Target number of participants
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100
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Interventions
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Clinical investigation by an experienced paediatrician and /or diagnosis of autism spectrum disorder with ADI-R/ADOS schedule. Participants collect urine overnight. The time span and quantity of urine, participants weight, length and age are ascertained. Analysis of most known urinary steroid metabolites with Gas Chromatography Mass Spectrometry (GCMS).
Participants are divided into 4 parallel groups
1. Autistic boys
2. Autistic girl
3. Healthy control boys
4. Healthy control girls
Statistical analysis is carried out by linear regression.
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Primary outcome measure(s)
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1. Measurement of about 50 hormones and steroid metabolites
2. Enzymatic hormone formation and metabolism activity in autistic disorders and in healthy state
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Secondary outcome measure(s)
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Relative hormone and steroid metabolite alteration due to age and gender
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Sources of funding
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Intersci Research Association (Austria)
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Trial website
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Publications
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Contact name
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Dr
Johann
Kurz
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Address
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Moosweg 8A
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City/town
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Bärnbach
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Zip/Postcode
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8572
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Country
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Austria
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Email
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joh.kurz@utanet.at
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Sponsor
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Intersci Research Association (Austria)
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Address
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Karl-Morre-Gasse 10
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City/town
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Liebnitz
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Zip/Postcode
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8430
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Country
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Austria
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Email
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joh.kurz@utanet.at
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Date applied
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20/06/2010
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Last edited
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14/09/2010
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Date ISRCTN assigned
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16/07/2010
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