Condition category
Mental and Behavioural Disorders
Date applied
20/06/2010
Date assigned
16/07/2010
Last edited
14/09/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes