Condition category
Mental and Behavioural Disorders
Date applied
11/05/2012
Date assigned
27/09/2012
Last edited
06/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Asperger’s syndrome is a developmental disorder which is often classified with a group of related conditions known as autistic spectrum disorders. Individuals with the disorder have average or above average intelligence and a well-developed speaking ability. Nevertheless, their social and communication skills are seriously affected, which leads to social isolation. The common symptoms of Asperger’s syndrome include obsessive adherence to routines, excessive passion in a single and narrow subject or topic, rhythmic and intonation problems of language, delayed motor skills and impaired social communication, interaction and imagination skills. Although certain drugs are given to treat anxiety, depression and aggression co-existing with this disorder, there is no known curative drug for the main symptoms of Asperger’s syndrome. Therefore, the mainstay management remains social skill training and behavior, occupational and speech therapies, and support and management training for parents. The long-chain polyunsatuated fatty acids (PUFAs) are vital components of the brain cell membranes and have been shown to influence neurological functions. There is evidence of insufficiency and imbalance of PUFA in persons with attention deficit hyperactivity disorder (ADHD), depression and autism spectrum disorders. The aim of this study is to investigate the benefits of PUFA in Polish children and adolescents with Asperger’s syndrome.

Who can participate?
Fifty children and adolescents, aged 6 to 19 years, with normal intelligence index and communication ability and diagnosed with Asperger’s syndrome and autism

What does the study involve?
The participants will be randomly allocated to be given either polyunsaturated fatty acid (PUFA) capsules or placebo (dummy) capsules for 3 months. After this period the participants who took the placebo tablets will take PUFA tablets for another 3 months.

What are the possible benefits and risks of participating?
Participants may experience an improvement in their clinical symptoms. PUFAs are nutrients commonly found in the diet. Hence, PUFAs do not present any risk to the participants.

Where is the study run from?
Indywidualna Specjalistyczna Praktyka Lekarska w Miejscu Wezwania (Poland).

When is the study starting and how long is it expected to run for?
The study started in October 2010 and is anticipated to be completed in August 2012.

Who is funding the study?
Vifor Pharma Ltd (Switzerland).

Who is the main contact?
Dr Beata Joanna Kozielec

Trial website

Contact information

Type

Scientific

Primary contact

Dr Beata Joanna Kozielec

ORCID ID

Contact details

Pelikanów 2d/8
Piaseczno
05-500
Poland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EQZ2007101

Study information

Scientific title

Benefits of PUFA supplementation in therapy of children and teenagers with Asperger’s Syndrome – pilot study

Acronym

PUFA AS

Study hypothesis

In this randomized double-blinded, placebo-controlled study researchers will observe expected changes in the behaviour of children witha diagnosis of Asperger’s Syndrome. The primary goal of this trial is to evaluate the benefits of diet supplementation with PUFA in children with Asperger’s Syndrome and 'well functioning' autism (with good speaking and normal intellectual abilities). The secondary goal is to evaluate the impact of PUFA supplementation with relation to initial parameters.

Ethics approval

Bioethics Committee of the Institute of Mother and Child, Warsaw, Poland, 21/11/2008, ref:19/2008

Study design

Double-blind randomized placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Asperger's syndrome

Intervention

Post randomization, the patients will be receive polyunsaturated fatty acid (n=25) or placebo (n=25) capsules for 3 months. This will be followed by a switch over of the placebo group to PUFA and further intervention for another 3 months.

Clinical symptoms and blood fatty acid status will be assessed at baseline and at two time points (3 and 6 months) during the intervention period.

Intervention type

Drug

Phase

Not Applicable

Drug names

Polyunsaturated fatty acids (PUFA)

Primary outcome measures

1. To evaluate the possible benefits of PUFA supplementation in patients with Asperger’s syndrome and autistic 'well functioning' children and teenagers with normal intelligence index and well-developed speaking abilities.
2. Changes in the core clinical symptoms pertaining to behavior and learning will be assessed by Conners Parent Rating Scales, psychiatric examination and questionnaire of symptoms, discussion with parents, based on ICD-10, Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV), Australian Scale for Asperger’s Syndrome of M.S. Garnett and A.J. Atwood, Asperger Syndrome Diagnostic Interview (ASDI) developed by the investigator.

Secondary outcome measures

To prepare initial indications to supplement subjects with Asperger’s syndrome and autistic 'well functioning' children and teenagers with PUFA, based on psychiatric and psychological evaluation, and blood tests.

Overall trial start date

01/01/2011

Overall trial end date

30/06/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis of Asperger’s syndrome according to ICD-10 (normal IQ)
2. Age 6 – 19 years

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

50

Participant exclusion criteria

Patients meeting at least one of below mentioned criteria (in the past or currently) will be excluded from participation in the study:
1. Bipolar disease
2. Psychotic disorders
3. Immunological disorders
4. Administration of PUFA or other fat supplements (e.g. lecithin) during last 3 months
5. Body mass index (BMI) lower than 18
6. Convulsions in the history (excluding high temperature convulsions)
7. Administration of epileptic drugs currently or in the past
8. Administration of alcohol or narcotic drugs during the last 3 months
9. Blood hypertension
10. Hyper- or hypothyroidism
11. Diabetes or glucose intolerance
12. Hyperlipidemia
13. Clotting abnormalities
14. Other acute or chronic diseases currently or in the past

Recruitment start date

01/01/2011

Recruitment end date

30/06/2012

Locations

Countries of recruitment

Poland

Trial participating centre

Pelikanów 2d/8
Piaseczno
05-500
Poland

Sponsor information

Organisation

Indywidualna Specjalistyczna Praktyka Lekarska w Miejscu Wezwania (Poland)

Sponsor details

c/o Dr Beata Joanna Kozielec
Pelikanów 2d/8
Piaseczno
05-500
Poland

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Vifor AG (Switzerland)

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