Contact information
Type
Scientific
Primary contact
Dr Johann Kurz
ORCID ID
Contact details
Moosweg 8A
Bärnbach
8572
Austria
joh.kurz@utanet.at
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT01197131
Protocol/serial number
1.0
Study information
Scientific title
Urinary Steroid Metabolites in Autism: An observational trial of 4 parallel groups
Acronym
USMiA
Study hypothesis
Widespread alteration of gene activation is contributed to alteration in hormone formation with elevated androgens in autism spectrum disorder
Ethics approval
The government ethics committee approved on the 12th of August 2010 (ref: FA8B-50.2-98/2010-4 )
Study design
Single centre observational 4 arm parallel group cohort trial
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Autism spectrum disorder, urinary steroid hormone metabolites
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Measurement of about 50 hormones and steroid metabolites
2. Enzymatic hormone formation and metabolism activity in autistic disorders and in healthy state
Secondary outcome measures
Relative hormone and steroid metabolite alteration due to age and gender
Overall trial start date
10/08/2010
Overall trial end date
30/06/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Epilepsy
2. Other severe illness
3. Pregnancy
4. Psychotropic medication
Recruitment start date
10/08/2010
Recruitment end date
30/06/2011
Locations
Countries of recruitment
Austria
Trial participating centre
Moosweg 8A
Bärnbach
8572
Austria
Sponsor information
Organisation
Intersci Research Association (Austria)
Sponsor details
Karl-Morre-Gasse 10
Liebnitz
8430
Austria
joh.kurz@utanet.at
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Intersci Research Association (Austria)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list