Omega-3 Fatty Acids For Treatment Of Young Children With Autism (OMG)

Autism Spectrum Disorder Clinical Trial

Official title:

A Randomized, Placebo-Controlled Trial of Omega-3 Fatty Acids in the Treatment of Young Children With Autism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01248728
• Other study ID #: 09-018
• Status: Completed
• Phase: Phase 2
• First received: November 22, 2010
• Last updated: June 19, 2014
• Start date: November 2010
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: Anagnostou, Evdokia, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

This is a pilot, randomized, placebo-controlled trial of omega-3 fatty acids in autism. Autism, originally described by Kanner in 1943, is among the most severe of neurodevelopmental disorders. It is a Pervasive Developmental Disorder affecting social and communicative functions and is also characterized by repetitive behaviors/restricted interests. It is also frequently accompanied by significant aggression, self-injury, irritability and hyperactivity, making care for these individuals an even greater challenge for families or institutional settings. Autism severely impacts the affected individual and family members, causing life-long functional impairment. In this protocol the investigators will use the terms "autism" and "autism spectrum disorder or ASD" interchangeably to refer to Autistic disorder, Asperger Syndrome and PDD-NOS.

Description:

Currently risperidone is the only medication approved the by Food and Drug Administration (FDA) for this disorder, and specifically for irritability associated with autism, although not all patients with autism respond to risperidone. No pharmacologic treatments have been approved for use in preschool children, although it is clear that early intervention is associated with improved outcomes. Behavioral and educational therapies play a significant role in the management of autistic symptoms. The history of alternative treatments in autism is notable for the exaggerated benefit of a variety of supplements, such as high dose vitamins (e.g. B6, magnesium), and secretin. The current widespread use of alternative/nutritional supplements to patients with autism without scientifically demonstrated efficacy, underscores the necessity for scientifically sound studies to be conducted. Complementary and alternative medical therapies (CAM) are commonly employed by families of autistic children. Recent surveys have estimated the prevalence of such use to be between 30% and 95% (1,2,3). Omega-3 fatty acids were reported to be used in 28.7% of patients (1). However, only two small case series and a very small randomized study have been reported in this population to date. The investigators propose to conduct a randomized controlled trial of omega-3 fatty acids in preschoolers with ASD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 5 Years

Eligibility

Inclusion Criteria:

1. Male or female outpatients 2-5 years of age.

2. Meet Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision criteria. DSM-IV criteria for an autism spectrum disorder, (Autistic disorder, Asperger syndrome or PDD-NOS) will be established by a clinician with expertise with individuals with ASD based on parent interview, Autism Diagnostic Observation Schedule (ADO) and Autism Diagnostic Interview (ADI-R)

3. If already receiving stable non pharmacologic educational, behavioral, dietary and or/ natural health product interventions during the preceding 3 months prior to Screening, will not electively initiate new or modify ongoing interventions for the duration of the study unless the child's condition is worsening or their turn comes up on the treatment waiting list.

4. Have normal physical examination and laboratory test results at Screening. If abnormal, the finding(s) must be deemed clinically insignificant by the Investigator.

5. The parents must be able to speak and understand English sufficiently to allow for the completion of all study assessments.

Exclusion Criteria:

1. Patients born prior to 35 weeks gestational age.

2. Patients with any primary psychiatric diagnosis other than autism at Screening. We are aware the most primary psychiatric disorders are unlikely to be diagnosed in this age group

3. Patients with a medical history of neurological disease, including, but not limited to, epilepsy/seizure disorder (except simple febrile seizures), movement disorder, tuberous sclerosis, fragile X, and any other known genetic syndromes, or known abnormal MRI/structural lesion of the brain.

4. Patients with a medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. Patients with evidence or history of malignancy or any significant hematological, endocrine, cardiovascular (including any rhythm disorder), respiratory, renal, hepatic, or gastrointestinal disease, or coagulation deficits.

5. Patients taking psychoactive medication(s) (e.g.,stimulants, antidepressants, antipsychotics, antiepileptics, anxiolytics, clonidine).

6. Patients that have been off pharmacotherapy for less than 6 weeks.

7. Patients who are participating in another clinical trial

8. Patients on anticoagulants

9. Patients who know that they will initiate or change nonpharmacologic interventions during the course of the study.

10. Patients unable to tolerate venipuncture procedures for blood sampling.

11. Patients taking Omega-3 supplements who have not discontinued treatment for six weeks prior to entering into the study.

12. Patients who have allergies to any of the ingredients in omega-3 (study product) or the placebo.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Dietary Supplement:
• Omega-3 Fatty Acids
Children will be administered 3.75ml of the liquid formulation of NutraSea HP (containing 1.5 gr of EPA+DHA). The starting dose will be 1.875ml (0.75 gr of EPA+DHA) and the dose will be doubled on week 2. The parents may choose to give this as a single dose or split it to two doses if stomach upset occurs. This formulation is double distilled and has very little fishy taste, which will make it more palatable for children and will make creating a matching placebo a simpler process.

Locations

Country	Name	City	State
Canada	Holland Bloorview Kids Rehabilitation Hospital	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Evdokia Anagnostou	Holland Bloorview Kids Rehabilitation Hospital, The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pervasive Developmental Disorder-Behavioral Inventory, PDDBI	The PDDBI measure autism symptomology	24 weeks	No
Primary	Behaviour Assessment System for Children (BASC-2)	The BASC-2 will be used to measure hyperactivity and aggressive behaviours.	24 weeks	No
Secondary	Clinical Global Impression CGI	The CGI-I provides a clinician assessed measure of improvement and as such is already inherently a measure of change.	24 weeks	Yes
Secondary	Vineland Adaptive Behavioral Scales (VABS)	the VABS is a measure of adaptive behaviour.	24 weeks	No
Secondary	Preschool Language Scale-4, PLS-4	The PLS-4 is a language measure.	24 weeks	No