Urinary Steroid Metabolites in Autism
| ISRCTN | ISRCTN18725918 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18725918 |
| ClinicalTrials.gov (NCT) | NCT01197131 |
| Protocol serial number | 1.0 |
| Sponsor | Intersci Research Association (Austria) |
| Funder | Intersci Research Association (Austria) |
- Submission date
- 20/06/2010
- Registration date
- 16/07/2010
- Last edited
- 08/03/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Johann Kurz
Scientific
Scientific
Moosweg 8A
Bärnbach
8572
Austria
| joh.kurz@utanet.at |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single centre observational 4 arm parallel group cohort trial |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Urinary Steroid Metabolites in Autism: An observational trial of 4 parallel groups |
| Study acronym | USMiA |
| Study objectives | Widespread alteration of gene activation is contributed to alteration in hormone formation with elevated androgens in autism spectrum disorder |
| Ethics approval(s) | The government ethics committee approved on the 12th of August 2010 (ref: FA8B-50.2-98/2010-4 ) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
1. Measurement of about 50 hormones and steroid metabolites |
| Key secondary outcome measure(s) |
Relative hormone and steroid metabolite alteration due to age and gender |
| Completion date | 30/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 15 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key 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 |
| Key exclusion criteria | 1. Epilepsy 2. Other severe illness 3. Pregnancy 4. Psychotropic medication |
| Date of first enrolment | 10/08/2010 |
| Date of final enrolment | 30/06/2011 |
Locations
Countries of recruitment
- Austria
Study participating centre
Moosweg 8A
Bärnbach
8572
Austria
8572
Austria
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
08/03/2019: Internal review.
