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Urinary Steroid Metabolites in Autism

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ClinicalTrials.gov Identifier: NCT01197131
Recruitment Status : Active, not recruiting
First Posted : September 9, 2010
Last Update Posted : December 27, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:

Deviation of hormone formation within nerve cells and nerve system provides autism spectrum disorder and neurodevelopment retardation through interaction of steroids with neurotransmitter-receptors, calcium-channel receptors and genomic interaction via nuclear steroid receptors.

Urinary steroid metabolites will be compared between children with autism spectrum disorder and healthy controls.

Condition or disease
Autism Autism Spectrum Disorder

Detailed Description:

Autism spectrum disorder presents many alterations in amino acid metabolism and in neurotransmitter systems (gamma amino acid system, glutamate-glutamine, nicotine-acid, serotonin-system) . Also alteration in gene activation within nerve cells and lymphocyte cultures encloses over 600 genes, affecting a wide field of enzymes , metabolic pathways and hormone formation. Male hormones and their precursors are often increased and their influence to nerve cell growth and spine formation is evident.

The diagnosis of autism spectrum disorder is made in accordance of criteria of the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) of the American Psychiatric Association by an experienced and specialised paediatrician or psychologist and /or by an Autism Diagnostic Interview-Revised (ADI-R) or Autism Diagnostic Observation Schedule (ADOS) .

Overnight urine with measurement of quantity and time will be collected and a little part of the urinary samples will be frozen for storage till analysis. Age, weight and length of the children at collection time will be ascertained.

Four stratified groups (autistic boys, girls, and healthy controls, boys and girls, each age 5-15) will be formed.

Urinary samples will further remain anonymous through an Identification-Number (ID).

Analysis of hormones and the most of the known metabolites excreted in urine will be performed by a specialised laboratory using gas chromatography-mass spectrometry (GC/MS) analysis (University Hospital Bern, Steroid Laboratory, Switzerland).

The statistical analysis, with age, gender, weight, diagnosis and hormone analysis results as factors , consists in linear regression analysis to detect deviation in hormone formation and metabolism.

Study Design

Study Type : Observational
Actual Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigation of Urinary Steroid Metabolites in Children With Autism Spectrum Disorder
Study Start Date : September 2010
Primary Completion Date : July 2011
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

autistic boys
Boys with autism spectrum disorder, age 5-15 years, diagnosis meets DSM-IV criteria ascertained by ADI-R or ADOS schedule or specialised paediatrician
autistic girls
Girls with autism spectrum disorder, age 5-15 years, diagnosis meets DSM-IV criteria ascertained by ADI-R or ADOS schedule or specialised paediatrician.
control boys
Healthy boys, age 5-15 years, mental status assessed by "Marburger Beurteilungsskala zum Asperger-Syndrome" (MBAS).
control girls
Healthy girls, age 5-15 years, mental status assessed by "Marburger Beurteilungsskala zum Asperger Syndrome" (MBAS).

Outcome Measures

Primary Outcome Measures :
  1. difference in hormone formation and androgen precursors [ Time Frame: 3 years ]
    Calculation of hormone formation by comparison of urinary steroid metabolites

Secondary Outcome Measures :
  1. difference in hormone formation in gender and age [ Time Frame: 3 years ]
    Hormone formation depends on age and gender and will be calculated by comparison of urinary steroid metabolites

Biospecimen Retention:   Samples Without DNA
noninvasive overnight urine (morning urine)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children , age 5-15 years with autism and autism spectrum disorder resident in Austria without other severe or psychiatric disorders.

Inclusion Criteria:

  • Autism spectrum disorder
  • Age 5-15 years

Exclusion Criteria:

  • Epilepsia
  • Psychotropic medication
  • other severe illness
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01197131

Intersci Research Association
Leibnitz, Steiermark, Austria, 8430
Sponsors and Collaborators
Intersci Research Association, Austria
Principal Investigator: Johann Kurz, MD Intersci Research Association, Austria
More Information

Responsible Party: Kurz Johann MD, Medical Doctor,, Intersci Research Association, Austria
ClinicalTrials.gov Identifier: NCT01197131     History of Changes
Other Study ID Numbers: protocol 1.0/18/06/2010
First Posted: September 9, 2010    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017

Keywords provided by Kurz Johann MD, Intersci Research Association, Austria:
autism spectrum disorder
steroid metabolites
urinary steroid metabolites
hormone formation
androgen precursor

Additional relevant MeSH terms:
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders