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Trial record 48 of 532 for:    Taste Disorders

Omega-3 Fatty Acids for Hyperactivity Treatment in Autism Spectrum Disorder

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ClinicalTrials.gov Identifier: NCT01694667
Recruitment Status : Completed
First Posted : September 27, 2012
Results First Posted : June 16, 2014
Last Update Posted : March 15, 2018
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Autism Spectrum Disorders
Hyperactivity
Interventions Drug: Omega-3 Fatty Acids
Other: Placebo
Enrollment 57
Recruitment Details Recruitment was limited to children between the ages of 5 and 8 with ASD and some verbal ability. E-mail invitations were sent to the 863 registered IAN members who met the above criteria and had given prior consent to be contacted about research opportunities between September 18, 2012 and October 31, 2012.
Pre-assignment Details During the six-week recruitment period, 118 families expressed interest and completed the on-line screening form. Fifty-seven children from 28 states were deemed eligible and randomly assigned to study treatment.
Arm/Group Title Omega-3 Fatty Acids Placebo
Hide Arm/Group Description

Omega-3 fatty acids will be delivered in orange-flavored pudding packets and will be given twice daily for a daily dose of 1.3 grams of omega-3 fatty acids (and 1.1 grams of DHA + EPA).

Omega-3 Fatty Acids: Omega-3 fatty acids will be delivered in orange-flavored pudding packets (Coromega®, Vista, CA). Each packet contains 650 mg of omega-3 fatty acids, 350mg of eicosapentanoic acid (EPA), 230mg of docosahexanoic acid (DHA) and 2,000 mg of fish oil 18/12, and will be given twice daily for a daily dose of 1.3 grams of omega-3 fatty acids (and 1.1 grams of DHA + EPA).

29 participants allocated to this group.

Placebo packets will have same orange-flavored pudding with an identical appearance and taste, but will include safflower oil instead of the fish oil.

Omega-3 Fatty Acids: Omega-3 fatty acids will be delivered in orange-flavored pudding packets (Coromega®, Vista, CA). Each packet contains 650 mg of omega-3 fatty acids, 350mg of eicosapentanoic acid (EPA), 230mg of docosahexanoic acid (DHA) and 2,000 mg of fish oil 18/12, and will be given twice daily for a daily dose of 1.3 grams of omega-3 fatty acids (and 1.1 grams of DHA + EPA).

28 participants allocated to this group.

Period Title: Overall Study
Started 29 28
Completed 29 28
Not Completed 0 0
Arm/Group Title Omega-3 Placebo Total
Hide Arm/Group Description Participants randomized to omega-3 Participants randomized to placebo Total of all reporting groups
Overall Number of Baseline Participants 29 28 57
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 29 participants 28 participants 57 participants
88.2  (12.3) 85.0  (13.2) 86.6  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 28 participants 57 participants
Female
3
  10.3%
4
  14.3%
7
  12.3%
Male
26
  89.7%
24
  85.7%
50
  87.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 28 participants 57 participants
American Indian or Alaska Native
1
   3.4%
0
   0.0%
1
   1.8%
Asian
1
   3.4%
1
   3.6%
2
   3.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   3.4%
3
  10.7%
4
   7.0%
White
24
  82.8%
23
  82.1%
47
  82.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   6.9%
1
   3.6%
3
   5.3%
ABC-Hyperactivity   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 29 participants 28 participants 57 participants
28.4  (8.4) 28.1  (7.6) 28.2  (8.0)
[1]
Measure Description:

Aberrant Behavior Checklist – measures problem behaviors independently and commonly used in children with autism 5 subscales are included and for each higher scores are worse. Each item uses a 0 to 3 Likert scale

Hyperactivity – 16 items, score ranges from 0-48

Irritability – 15 items, score ranges from 0-45

Stereotypy – 7 questions, score ranges from 0-21

Lethargy – 16 questions, score ranges from 0-48

Inappropriate speech – 4 questions, score ranges from 0-12

Subscales were not combined to compute a total score.

ABC-Irritability   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 29 participants 28 participants 57 participants
20.0  (8.9) 16.8  (8.3) 18.4  (8.7)
[1]
Measure Description:

Aberrant Behavior Checklist – measures problem behaviors independently and commonly used in children with autism 5 subscales are included and for each higher scores are worse. Each item uses a 0 to 3 Likert scale

Hyperactivity – 16 items, score ranges from 0-48

Irritability – 15 items, score ranges from 0-45

Stereotypy – 7 questions, score ranges from 0-21

Lethargy – 16 questions, score ranges from 0-48

Inappropriate speech – 4 questions, score ranges from 0-12

Subscales were not combined to compute a total score.

ABC-Stereotypy   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 29 participants 28 participants 57 participants
8.0  (6.0) 5.4  (4.7) 6.7  (5.5)
[1]
Measure Description:

Aberrant Behavior Checklist – measures problem behaviors independently and commonly used in children with autism 5 subscales are included and for each higher scores are worse. Each item uses a 0 to 3 Likert scale

Hyperactivity – 16 items, score ranges from 0-48

Irritability – 15 items, score ranges from 0-45

Stereotypy – 7 questions, score ranges from 0-21

Lethargy – 16 questions, score ranges from 0-48

Inappropriate speech – 4 questions, score ranges from 0-12

Subscales were not combined to compute a total score.

ABC-Lethargy   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 29 participants 28 participants 57 participants
12.2  (8.8) 8.8  (4.2) 10.5  (7.1)
[1]
Measure Description:

Aberrant Behavior Checklist – measures problem behaviors independently and commonly used in children with autism 5 subscales are included and for each higher scores are worse. Each item uses a 0 to 3 Likert scale

Hyperactivity – 16 items, score ranges from 0-48

Irritability – 15 items, score ranges from 0-45

Stereotypy – 7 questions, score ranges from 0-21

Lethargy – 16 questions, score ranges from 0-48

Inappropriate speech – 4 questions, score ranges from 0-12

Subscales were not combined to compute a total score.

ABC-Inappropriate Speech   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 29 participants 28 participants 57 participants
7.0  (3.4) 5.8  (2.8) 6.4  (3.2)
[1]
Measure Description:

Aberrant Behavior Checklist – measures problem behaviors independently and commonly used in children with autism 5 subscales are included and for each higher scores are worse. Each item uses a 0 to 3 Likert scale

Hyperactivity – 16 items, score ranges from 0-48

Irritability – 15 items, score ranges from 0-45

Stereotypy – 7 questions, score ranges from 0-21

Lethargy – 16 questions, score ranges from 0-48

Inappropriate speech – 4 questions, score ranges from 0-12

Subscales were not combined to compute a total score.

1.Primary Outcome
Title Change in Aberrant Behavior Checklist - Hyperactivity Subscale (ABC-H) Score
Hide Description The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from "0=no problem" to "3=major problem." Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The hyperactivity subscale is comprised of 16 items. The outcome measure is the change from baseline to 6 weeks. The total score ranges from 0 to 48.
Time Frame Baseline, 6 weeks (3 week value to be collected)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Omega-3 Placebo
Hide Arm/Group Description:
Participants randomized to omega-3
Participants randomized to placebo
Overall Number of Participants Analyzed 29 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.3  (7.2) -3.4  (7.5)
2.Secondary Outcome
Title Change in Aberrant Behavior Checklist - Lethargy Subscale Score
Hide Description The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from "0=no problem" to "3=major problem." Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The lethargy subscale is comprised of 16 items. The outcome measure is the change from baseline to six weeks in the scale. Total score ranges from 0 to 48.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Omega-3 Placebo
Hide Arm/Group Description:
Participants randomized to omega-3
Participants randomized to placebo
Overall Number of Participants Analyzed 29 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.1  (4.2) 0.1  (2.6)
3.Secondary Outcome
Title Change in Aberrant Behavior Checklist - Stereotypy Subscale Score
Hide Description The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from "0=no problem" to "3=major problem." Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The stereotypy subscale is comprised of 7 items. The outcome measure is the change from baseline to six weeks in the scale. Total score ranges from 0 to 21.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Omega-3 Placebo
Hide Arm/Group Description:
Participants randomized to omega-3
Participants randomized to placebo
Overall Number of Participants Analyzed 29 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.0  (3.7) -0.5  (2.6)
4.Secondary Outcome
Title Aberrant Behavior Checklist - Irritability Subscale Score
Hide Description The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from "0=no problem" to "3=major problem." Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The irritability subscale is comprised of 15 items. The outcome measure is the change from baseline to six weeks in the scale. Total score ranges from 0 to 45.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Omega-3 Placebo
Hide Arm/Group Description:
Participants randomized to omega-3
Participants randomized to placebo
Overall Number of Participants Analyzed 29 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.0  (6.9) -2.1  (4.4)
5.Secondary Outcome
Title Aberrant Behavior Checklist - Inappropriate Speech Subscale Score
Hide Description The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from "0=no problem" to "3=major problem." Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The inappropriate speech subscale is comprised of 4 items. The outcome measure is the change from baseline to six weeks in the scale. Total score ranges from 0 to 12.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Omega-3 Placebo
Hide Arm/Group Description:
Participants randomized to omega-3
Participants randomized to placebo
Overall Number of Participants Analyzed 29 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.6  (2.7) -0.9  (2.2)
6.Secondary Outcome
Title Change in Social Responsiveness Scale (SRS) Score
Hide Description Social interaction will be assessed with the SRS. This scale examines the presence and extent of autistic social impairment and is administered by parents or teachers of children with ASD. Higher scores are indicative of greater severity. Normative data have been derived from a sample of over 1,600 children.
Time Frame Baseline, Week 6
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Change in Clinical Global Impression - Improvement (CGI-I) Score
Hide Description Measures the clinical impression of improvement on a 7-point Likert scale (ranging from 1 - very much improved - to 7 - very much worse) is a commonly used measure of overall improvement in intervention studies of children with ASD. This tool will be completed by the parent and caregiver, and is therefore considered a modified version of the instrument, which is normally completed by a clinician. This is considered an exploratory analysis of this outcome tool since it is being used in a non-standard fashion. The number of participants who "responded" in each group is the number where the parents reported that their child was improved, much improved, or very much improved.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Omega-3 Placebo
Hide Arm/Group Description:
Participants randomized to omega-3
Participants randomized to placebo
Overall Number of Participants Analyzed 29 28
Measure Type: Number
Unit of Measure: # parents reporting improvement
12 10
Time Frame 6 weeks
Adverse Event Reporting Description
  • Families advised at start of study to contact study coordinator if child experiences a new health problem.
  • Families sent weekly e-mail which includes form asking about new health problems. If “yes”, study doctor contacted and reviews form and contacts participant to obtain additional info and determine if further medical evaluation/treatment required.

AE form questions are standard questions on FDA serious adverse event (SAE) forms.

 
Arm/Group Title Omega-3 Placebo
Hide Arm/Group Description Participants randomized to omega-3 Participants randomized to placebo
All-Cause Mortality
Omega-3 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Omega-3 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/29 (0.00%)      0/28 (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 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/29 (34.48%)      6/28 (21.43%)    
Eye disorders     
Conjunctivitis   0/29 (0.00%)  0 1/28 (3.57%)  1
Gastrointestinal disorders     
Gastrointestinal virus   1/29 (3.45%)  1 0/28 (0.00%)  0
vomitting   2/29 (6.90%)  2 0/28 (0.00%)  0
Infections and infestations     
sinus infection   0/29 (0.00%)  0 1/28 (3.57%)  1
Psychiatric disorders     
Increased self-stimulatory behavior   1/29 (3.45%)  1 0/28 (0.00%)  0
Increased tantrums   2/29 (6.90%)  2 0/28 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Asthma Flare   0/29 (0.00%)  0 1/28 (3.57%)  1
Croup   1/29 (3.45%)  1 0/28 (0.00%)  0
Cough   0/29 (0.00%)  0 1/28 (3.57%)  1
Pneumonia   0/29 (0.00%)  0 1/28 (3.57%)  1
Viral upper respiratory infection   0/29 (0.00%)  0 1/28 (3.57%)  1
Skin and subcutaneous tissue disorders     
rash   1/29 (3.45%)  1 0/28 (0.00%)  0
Surgical and medical procedures     
Elective Tonsillectomy   1/29 (3.45%)  1 0/28 (0.00%)  0
Vascular disorders     
Nosebleed   1/29 (3.45%)  1 0/28 (0.00%)  0
Indicates events were collected by 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: Stephen Bent
Organization: University of California, San Francisco
Phone: 415-221-4810 ext 3457
Responsible Party: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier: NCT01694667     History of Changes
Other Study ID Numbers: NA_00068694
First Submitted: March 26, 2012
First Posted: September 27, 2012
Results First Submitted: April 3, 2014
Results First Posted: June 16, 2014
Last Update Posted: March 15, 2018