Urinary Steroid Metabolites in Autism
| ISRCTN | ISRCTN18725918 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18725918 |
| ClinicalTrials.gov number | NCT01197131 |
| Secondary identifying numbers | 1.0 |
- 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
| Study design | Single centre observational 4 arm parallel group cohort trial |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details below to request a patient 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 | 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 study start date | 10/08/2010 |
| Completion date | 30/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 15 Years |
| Sex | Both |
| Target number of participants | 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
Sponsor information
Intersci Research Association (Austria)
Charity
Charity
Karl-Morre-Gasse 10
Liebnitz
8430
Austria
| joh.kurz@utanet.at |
Funders
Funder type
Charity
Intersci Research Association (Austria)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
08/03/2019: Internal review.
