Benefits of polyunsaturated fatty acid (PUFA) supplementation in therapy of children and teenagers with Aspergers Syndrome

ISRCTN	ISRCTN20233876
DOI	https://doi.org/10.1186/ISRCTN20233876
Secondary identifying numbers	EQZ2007101

Submission date: 11/05/2012
Registration date: 27/09/2012
Last edited: 06/06/2014

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

Background and study aims
Aspergers 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 Aspergers 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 Aspergers 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 Aspergers syndrome.

Who can participate?
Fifty children and adolescents, aged 6 to 19 years, with normal intelligence index and communication ability and diagnosed with Aspergers 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

Contact information

Dr Beata Joanna Kozielec
Scientific

Pelikanów 2d/8
Piaseczno
05-500
Poland

Study information

Study design	Double-blind randomized placebo-controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Benefits of PUFA supplementation in therapy of children and teenagers with Aspergers Syndrome pilot study
Study acronym	PUFA AS
Study objectives	In this randomized double-blinded, placebo-controlled study researchers will observe expected changes in the behaviour of children witha diagnosis of Aspergers Syndrome. The primary goal of this trial is to evaluate the benefits of diet supplementation with PUFA in children with Aspergers 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(s)	Bioethics Committee of the Institute of Mother and Child, Warsaw, Poland, 21/11/2008, ref:19/2008
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Polyunsaturated fatty acids (PUFA)
Primary outcome measure	1. To evaluate the possible benefits of PUFA supplementation in patients with Aspergers 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 Aspergers 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 Aspergers syndrome and autistic 'well functioning' children and teenagers with PUFA, based on psychiatric and psychological evaluation, and blood tests.
Overall study start date	01/01/2011
Completion date	30/06/2012

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Years
Upper age limit	19 Years
Sex	Both
Target number of participants	50
Key inclusion criteria	1. Diagnosis of Aspergers syndrome according to ICD-10 (normal IQ) 2. Age 6 19 years
Key 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
Date of first enrolment	01/01/2011
Date of final enrolment	30/06/2012

Locations

Countries of recruitment

Poland

Study participating centre

Pelikanów 2d/8

Piaseczno
05-500
Poland

Sponsor information

Indywidualna Specjalistyczna Praktyka Lekarska w Miejscu Wezwania (Poland)
Hospital/treatment centre

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

Funders

Funder type

Industry

Vifor AG (Switzerland)

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

Benefits of polyunsaturated fatty acid (PUFA) supplementation in therapy of children and teenagers with Aspergers Syndrome