Trial Outcomes & Findings for Omega-3 Fatty Acids for Autism Treatment (NCT NCT00786799)

NCT ID: NCT00786799

Last Updated: 2012-08-31

Results Overview

Hyperactivity subscale of Aberrant Behavior checklist (ABC-H): measure of assessing changes in symptoms of hyperactivity in children with autism (survey that was normed on a developmentally delayed population of children and adults and is usually completed by a parent or caregiver. Items are rated on a 4-point scale from "no problem" to "major problem"). ABC-H Subscale Score ranges from 0 (best) to 45 (worst). A negative change signifies improvement.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 27 participants
• Primary outcome timeframe: Baseline and 1 year
• Results posted on: 2012-08-31

Participant Flow

Participant milestones

Measure	Omega-3 Fatty Acids Omega-3 fatty acids were provided as orange-flavored pudding packets (Coromega®, Vista, CA) containing 650 mg of omega-3 fatty acids, including 350 mg of eicosapentanoic acid (EPA) and 230 mg of docosahexanoic acid (DHA), given twice daily for a daily dose of 1.3 g of omega-3 fatty acids (and 1.1 g of DHA + EPA).	Placebo Placebo packets had the same orange-flavored pudding with an identical appearance and taste, but included safflower oil instead of the fish oil (omega-3 fatty acids). Safflower oil was used because it is has a similar texture and is comprised of fatty acids (but not omega-3 fatty acids), and this allowed for an examination of the unique of effects of omega-3 fatty acids compared to "non-omega-3" fatty acids.
Overall Study STARTED	14	13
Overall Study COMPLETED	13	12
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Omega-3 Fatty Acids Omega-3 fatty acids were provided as orange-flavored pudding packets (Coromega®, Vista, CA) containing 650 mg of omega-3 fatty acids, including 350 mg of eicosapentanoic acid (EPA) and 230 mg of docosahexanoic acid (DHA), given twice daily for a daily dose of 1.3 g of omega-3 fatty acids (and 1.1 g of DHA + EPA).	Placebo Placebo packets had the same orange-flavored pudding with an identical appearance and taste, but included safflower oil instead of the fish oil (omega-3 fatty acids). Safflower oil was used because it is has a similar texture and is comprised of fatty acids (but not omega-3 fatty acids), and this allowed for an examination of the unique of effects of omega-3 fatty acids compared to "non-omega-3" fatty acids.
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

Omega-3 Fatty Acids for Autism Treatment

Baseline characteristics by cohort

Measure	Omega-3 Fatty Acids n=14 Participants Omega-3 fatty acids were provided as orange-flavored pudding packets (Coromega®, Vista, CA) containing 650 mg of omega-3 fatty acids, including 350 mg of eicosapentanoic acid (EPA) and 230 mg of docosahexanoic acid (DHA), given twice daily for a daily dose of 1.3 g of omega-3 fatty acids (and 1.1 g of DHA + EPA).	Placebo n=13 Participants Placebo packets had the same orange-flavored pudding with an identical appearance and taste, but included safflower oil instead of the fish oil (omega-3 fatty acids). Safflower oil was used because it is has a similar texture and is comprised of fatty acids (but not omega-3 fatty acids), and this allowed for an examination of the unique of effects of omega-3 fatty acids compared to "non-omega-3" fatty acids.	Total n=27 Participants Total of all reporting groups
Age, Categorical <=18 years	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	5.85 years STANDARD_DEVIATION 1.83 • n=5 Participants	5.82 years STANDARD_DEVIATION 1.42 • n=7 Participants	5.83 years STANDARD_DEVIATION 1.67 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	13 participants n=7 Participants	27 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 1 year

Hyperactivity subscale of Aberrant Behavior checklist (ABC-H): measure of assessing changes in symptoms of hyperactivity in children with autism (survey that was normed on a developmentally delayed population of children and adults and is usually completed by a parent or caregiver. Items are rated on a 4-point scale from "no problem" to "major problem"). ABC-H Subscale Score ranges from 0 (best) to 45 (worst). A negative change signifies improvement.

Outcome measures

Measure	Active Omega-3 n=13 Participants Mean and Standard Deviation of Change in Aberrant Behavior Checklist-Hyperactivity Subscale Score within Omega-3 Group Only	Placebo n=12 Participants Mean and Standard Deviation of Change in Aberrant Behavior Checklist-Hyperactivity Subscale Score within Placebo Group Only	Comparison Between Omega-3 and Placebo Groups n=25 Participants Comparison of Change in Aberrant Behavior Checklist-Hyperactivity Subscale Score between Omega-3 and Placebo groups (p-value given in statistical analysis section)
Group-specific and Comparison of Change in Aberrant Behavior Checklist-Hyperactivity Subscale Score (Active Omega-3 Group Only, Placebo Group Only and Comparison Between Groups)	2.7 scores on a scale Standard Deviation 4.8	0.3 scores on a scale Standard Deviation 7.2	2.3 scores on a scale Standard Deviation 6.1

SECONDARY outcome

Timeframe: Baseline and 1 year

Change in percentage calculated as (100% * ((One Year - Baseline)/Baseline)

Outcome measures

Measure	Active Omega-3 n=13 Participants Mean and Standard Deviation of Change in Aberrant Behavior Checklist-Hyperactivity Subscale Score within Omega-3 Group Only	Placebo n=12 Participants Mean and Standard Deviation of Change in Aberrant Behavior Checklist-Hyperactivity Subscale Score within Placebo Group Only	Comparison Between Omega-3 and Placebo Groups Comparison of Change in Aberrant Behavior Checklist-Hyperactivity Subscale Score between Omega-3 and Placebo groups (p-value given in statistical analysis section)
Change in Percentage of Serum Omega-3 Fatty Acids	2.54 Percent change of levels of fatty acid Standard Deviation 2.8	-0.10 Percent change of levels of fatty acid Standard Deviation 0.3	—

SECONDARY outcome

Timeframe: Baseline and 1 year

Outcome measures

Measure	Active Omega-3 n=13 Participants Mean and Standard Deviation of Change in Aberrant Behavior Checklist-Hyperactivity Subscale Score within Omega-3 Group Only	Placebo n=12 Participants Mean and Standard Deviation of Change in Aberrant Behavior Checklist-Hyperactivity Subscale Score within Placebo Group Only	Comparison Between Omega-3 and Placebo Groups Comparison of Change in Aberrant Behavior Checklist-Hyperactivity Subscale Score between Omega-3 and Placebo groups (p-value given in statistical analysis section)
Change in Serum TNFα (Cytokine) Level	1.3 pg/ml Standard Deviation 2.5	-0.9 pg/ml Standard Deviation 2.1	—

Adverse Events

Omega-3 Fatty Acids

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Omega-3 Fatty Acids n=14 participants at risk Omega-3 fatty acids were provided as orange-flavored pudding packets (Coromega®, Vista, CA) containing 650 mg of omega-3 fatty acids, including 350 mg of eicosapentanoic acid (EPA) and 230 mg of docosahexanoic acid (DHA), given twice daily for a daily dose of 1.3 g of omega-3 fatty acids (and 1.1 g of DHA + EPA).	Placebo n=13 participants at risk Placebo packets had the same orange-flavored pudding with an identical appearance and taste, but included safflower oil instead of the fish oil (omega-3 fatty acids). Safflower oil was used because it is has a similar texture and is comprised of fatty acids (but not omega-3 fatty acids), and this allowed for an examination of the unique of effects of omega-3 fatty acids compared to "non-omega-3" fatty acids.
Skin and subcutaneous tissue disorders Rash	14.3% 2/14 • Number of events 2	0.00% 0/13
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	7.1% 1/14 • Number of events 1	0.00% 0/13
Blood and lymphatic system disorders Nose Bleed	7.1% 1/14 • Number of events 1	0.00% 0/13
Gastrointestinal disorders GI Symptoms	7.1% 1/14 • Number of events 1	0.00% 0/13
Nervous system disorders Increased Hyperactivity	0.00% 0/14	23.1% 3/13 • Number of events 3
Nervous system disorders Increased Self-Stimulating Behavior	0.00% 0/14	7.7% 1/13 • Number of events 1

Additional Information

Robert L. Hendren, D.O.

University of California, San Francisco

Phone: 415-476-7198

Email: robert.hendren@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place