Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 83 for:    Developmental Disabilities | ( Map: Canada )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01248728
Recruitment Status : Completed
First Posted : November 25, 2010
Results First Posted : May 18, 2016
Last Update Posted : May 18, 2016
Sponsor:
Collaborators:
Holland Bloorview Kids Rehabilitation Hospital
The Hospital for Sick Children
Information provided by (Responsible Party):
Evdokia Anagnostou, Anagnostou, Evdokia, M.D.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Autism Spectrum Disorder
Interventions Dietary Supplement: Omega-3 Fatty Acids
Dietary Supplement: Placebo
Enrollment 38
Recruitment Details Participants were recruited from the hospital clinical database, as well as presentations at local conferences and media. Diagnosis was established using the Diagnostic and Statistical Manual, Fourth Edition for an Autism Spectrum Disorder supported by the Autism Diagnostic Observations Schedule and the Autism Diagnostic Interview - Revised.
Pre-assignment Details Participants were randomized to the two arms in a 1:1 fashion by the pharmacy, based on a randomization schedule produced by the study biostatistician. They were stratified into one of four strata based on the PDDBI score obtained at screening (four quartiles).
Arm/Group Title Omega-3 Fatty Acids Placebo
Hide Arm/Group Description

Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP.

If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.

The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor.

Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo.

If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.

The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor.

Period Title: Overall Study
Started 19 19
Completed 15 17
Not Completed 4 2
Reason Not Completed
Adverse Event             1             1
Withdrawal by Subject             2             1
Lack of Efficacy             1             0
Arm/Group Title Omega-3 Fatty Acids Placebo Total
Hide Arm/Group Description

Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP.

If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.

The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor.

Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo.

If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.

The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor.

Total of all reporting groups
Overall Number of Baseline Participants 19 19 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
<=18 years
19
 100.0%
19
 100.0%
38
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
Female
4
  21.1%
6
  31.6%
10
  26.3%
Male
15
  78.9%
13
  68.4%
28
  73.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 19 participants 19 participants 38 participants
19 19 38
1.Primary Outcome
Title Change From Baseline in the Pervasive Developmental Disorder-Behavioral Inventory (PDDBI) - Autism Composite Score
Hide Description

The PDDBI measures autism symptomology. The autism composite score was used as the primary outcome measure for autism symptom severity.

PDDBI Autism Composite Scale Range:

Minimum Range = 10 (lower autism symptom severity) Maximum Range = 100 (higher autism symptom severity)

The Autism Composite is calculated from the sum of T-scores of the Sensory/Perceptual Approach Behaviours, Ritualisms/Resistance to Change, Social Pragmatic Problems, and Semantic/Pragmatic Problems domains subtracted by the sum of T-scores of the Social Approach Behaviours, and Expressive Language domain then converted into the Autism Composite as a T-score.

Mean change between baseline and week 24 is reported. A negative change indicates improvement

Time Frame Baseline and 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
1 participant was dropped from the analysis in the Omega-3 group as there was insufficient data due to early termination.
Arm/Group Title Omega-3 Fatty Acids Placebo
Hide Arm/Group Description:

Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP.

If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.

The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor.

Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo.

If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.

The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor.

Overall Number of Participants Analyzed 18 19
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-4.5
(-8.5 to -0.6)
-6.4
(-10.2 to -2.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omega-3 Fatty Acids, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in the Behaviour Assessment System for Children (BASC-2) - Externalizing Problems Composite
Hide Description

The BASC-2 externalizing problems composite measures hyperactivity and aggressive behaviours.

Primary Outcome domain: Externalizing Problems composite

Externalizing Problems Composite T-Score Range:

Minimum Range: 10 (lower externalizing problems) Maximum Range: 120 (higher externalizing problems)

The Externalizing Problems composite is computed from the sum of t-scores from the hyperactivity and aggression subscales then converted into the externalizing problems composite t-score.

Mean change between baseline and week 24 is reported. A negative change indicates improvement.

Time Frame Baseline and 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
1 participant was dropped from the analysis in the Omega-3 group as there was insufficient data due to early termination.
Arm/Group Title Omega-3 Fatty Acids Placebo
Hide Arm/Group Description:
Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor.
Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor.
Overall Number of Participants Analyzed 18 19
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
3.2
(-0.5 to 6.9)
-3.0
(-6.6 to 0.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omega-3 Fatty Acids, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants Classified as Responders by the Clinical Global Impression - Improvement (CGI-I)
Hide Description

The CGI-I is a seven-point scale that provides a clinician rating of global improvement and as such is already inherently a measure of change. It requires the clinician to assess the degree to which the participant's illness has improved or worsened relative to a baseline state before the intervention.

Change is rated as:

0- Not assessed

  1. Very Much Improved
  2. Much Improved
  3. Minimally Improved
  4. No Change
  5. Minimally Worse
  6. Much Worse
  7. Very Much Worse

Participants are classified as responders if their CGI-I score was 1 or 2 and non-responders for CGI-I scores of 3 to 7.

Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
1 participant was dropped from the analysis in the Omega-3 group as there was insufficient data due to early termination.
Arm/Group Title Omega-3 Fatty Acids Placebo
Hide Arm/Group Description:
Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor.
Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor.
Overall Number of Participants Analyzed 18 19
Measure Type: Number
Unit of Measure: participants classified as responders
12 12
4.Secondary Outcome
Title Change From Baseline in the Vineland Adaptive Behavioral Scales (VABS) - Adaptive Functioning Composite
Hide Description

The VABS is a measure of adaptive behavior in daily settings. Secondary measure domain: The adaptive functioning composite describes an individuals overall functioning

Adaptive Behaviour Composite Standard Score Range:

Minimum range: 20 (low adaptive functioning) Maximum range: 160 (high adaptive functioning)

The adaptive behaviour composite standard score is computed from the sum of standard scores from the communication, daily living skills, socialization and motor skills domains and converted into the adaptive behavior composite standard score.

Change in the adaptive behaviour composite standard score from baseline to week 24 is reported. Positive change indicates improvement.

Time Frame Baseline and 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
1 participant was dropped from the analysis in the Omega-3 group as there was insufficient data due to early termination.
Arm/Group Title Omega-3 Fatty Acids Placebo
Hide Arm/Group Description:
Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor.
Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor.
Overall Number of Participants Analyzed 18 19
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
2.8
(0.2 to 5.3)
-0.2
(-2.6 to 2.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omega-3 Fatty Acids, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in the Preschool Language Scale (PLS-4) - Total Language
Hide Description

The PLS-4 is a language measure that provides a global assessment of a child's language functioning abilities, receptive and expressive language.

Secondary outcome measure domain: Total language standard score

Total Language Standard Score Range:

Minimum range: 50 (lower language abilities) Maximum range: 150 (higher language abilities)

The total language standard score is computed from a sum of the auditory comprehension and expressive communication standard scores, then converted into the total language standard score.

Change of total language standard scores from baseline to week 24 is reported. Positive change indicates improvement

Time Frame Baseline and 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
1 participant was dropped from the analysis in the Omega-3 group as there was insufficient data due to early termination.
Arm/Group Title Omega-3 Fatty Acids Placebo
Hide Arm/Group Description:
Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor.
Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor.
Overall Number of Participants Analyzed 18 19
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.7
(-2.7 to 4.1)
-0.6
(-3.7 to 2.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omega-3 Fatty Acids, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Omega-3 Fatty Acids Placebo
Hide Arm/Group Description

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.

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.

Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo.

If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.

The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor.

All-Cause Mortality
Omega-3 Fatty Acids Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Omega-3 Fatty Acids Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/19 (0.00%)      0/19 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Omega-3 Fatty Acids Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/19 (100.00%)      19/19 (100.00%)    
Ear and labyrinth disorders     
Earache   3/19 (15.79%)  3 0/19 (0.00%)  0
Eye disorders     
Eye Swelling   1/19 (5.26%)  1 0/19 (0.00%)  0
Nearsightedness   1/19 (5.26%)  1 0/19 (0.00%)  0
Red Eyes   0/19 (0.00%)  0 1/19 (5.26%)  1
Gastrointestinal disorders     
Abdominal Pain   3/19 (15.79%)  6 3/19 (15.79%)  4
Regurgitation   1/19 (5.26%)  1 0/19 (0.00%)  0
Vomiting   4/19 (21.05%)  4 3/19 (15.79%)  3
Diarrhea   5/19 (26.32%)  5 8/19 (42.11%)  9
Constipation   6/19 (31.58%)  7 6/19 (31.58%)  7
Gastroenteritis   1/19 (5.26%)  1 2/19 (10.53%)  2
General disorders     
Decreased Energy   3/19 (15.79%)  4 2/19 (10.53%)  2
Infections and infestations     
Upper Respiratory Infection   16/19 (84.21%)  23 14/19 (73.68%)  24
Fever *  4/19 (21.05%)  4 4/19 (21.05%)  5
Ear Infection   1/19 (5.26%)  1 3/19 (15.79%)  3
Skin Infection   1/19 (5.26%)  1 1/19 (5.26%)  1
Hand Mouth Foot Disease   0/19 (0.00%)  0 1/19 (5.26%)  2
Roseola   0/19 (0.00%)  0 1/19 (5.26%)  1
Bronchiolitis  0/19 (0.00%)  0 3/19 (15.79%)  3
Hand Mouth Foot Disease  0/19 (0.00%)  0 1/19 (5.26%)  2
Injury, poisoning and procedural complications     
Left Knee Injury   0/19 (0.00%)  0 1/19 (5.26%)  1
Metabolism and nutrition disorders     
Increased Appetite   1/19 (5.26%)  1 0/19 (0.00%)  0
Decreased Appetite   6/19 (31.58%)  7 2/19 (10.53%)  3
Decreased Dietary Variety   1/19 (5.26%)  1 0/19 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Muscle Aches   1/19 (5.26%)  1 0/19 (0.00%)  0
Right Leg Internal Rotation   1/19 (5.26%)  1 0/19 (0.00%)  0
Nervous system disorders     
Headache   1/19 (5.26%)  1 0/19 (0.00%)  0
Initial Insomnia  5/19 (26.32%)  6 4/19 (21.05%)  4
Mid-cycle Insomnia  3/19 (15.79%)  6 2/19 (10.53%)  3
Early Awakening  1/19 (5.26%)  1 0/19 (0.00%)  0
Non-restorative Sleep  1/19 (5.26%)  1 0/19 (0.00%)  0
Nightmares  1/19 (5.26%)  1 1/19 (5.26%)  1
Psychiatric disorders     
Overactivity   3/19 (15.79%)  3 0/19 (0.00%)  0
Social Communicative Intent Loss   1/19 (5.26%)  1 1/19 (5.26%)  1
Staring Spell   1/19 (5.26%)  1 0/19 (0.00%)  0
Increased Emotional Lability   1/19 (5.26%)  1 2/19 (10.53%)  3
Increased Irritability/Anger/Aggression   7/19 (36.84%)  10 2/19 (10.53%)  4
Stuttering   1/19 (5.26%)  1 0/19 (0.00%)  0
Renal and urinary disorders     
Daytime Wetting   1/19 (5.26%)  1 0/19 (0.00%)  0
Pain on Urination   0/19 (0.00%)  0 1/19 (5.26%)  1
Change in Urine Colour   0/19 (0.00%)  0 1/19 (5.26%)  1
Respiratory, thoracic and mediastinal disorders     
Nose Bleed   0/19 (0.00%)  0 3/19 (15.79%)  3
Nasal Congestion   1/19 (5.26%)  2 1/19 (5.26%)  1
Cough   2/19 (10.53%)  3 3/19 (15.79%)  4
Skin and subcutaneous tissue disorders     
Rash   6/19 (31.58%)  10 9/19 (47.37%)  9
Eczema   2/19 (10.53%)  2 3/19 (15.79%)  4
Bruising   3/19 (15.79%)  4 1/19 (5.26%)  2
Dry Skin   1/19 (5.26%)  1 2/19 (10.53%)  2
Flaky Scalp   0/19 (0.00%)  0 1/19 (5.26%)  1
Surgical and medical procedures     
Eye Surgery   1/19 (5.26%)  1 0/19 (0.00%)  0
Tonsillectomy   0/19 (0.00%)  0 1/19 (5.26%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Evdokia Anagnostou
Organization: Holland Bloorview Kids Rehabilitation Hospital
Phone: 416-425-6220 ext 6005
Responsible Party: Evdokia Anagnostou, Anagnostou, Evdokia, M.D.
ClinicalTrials.gov Identifier: NCT01248728     History of Changes
Other Study ID Numbers: 09-018
First Submitted: November 22, 2010
First Posted: November 25, 2010
Results First Submitted: December 16, 2015
Results First Posted: May 18, 2016
Last Update Posted: May 18, 2016