Autism Spectrum DisordersPhase 2NCT01694667
Omega-3 Fatty Acids for Hyperactivity Treatment in Autism Spectrum Disorder
A Phase 2 study testing Omega-3 Fatty Acids in people with Autism Spectrum Disorders and Hyperactivity, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
Trial summary
The proposed study is an internet-based, randomized, double-blind, placebo-controlled trial which will assess changes in hyperactivity in children ages five through eight with an autism spectrum disorders (ASD) and elevated levels of hyperactivity. Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Autism Spectrum Disorders, Hyperactivity
- What is being tested?
- Omega-3 Fatty Acids
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to May 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children who are participating in Interactive Autism Network (IAN) Research Families
- Diagnosis of (Autism Spectrum Disorders (ASD) by a professional and Social Communication Question (SCQ) score>12
- Age 5-8
- Aberrant Behavior Checklist - Hyperactivity subscale (ABC-H)>20
Who cannot join
- Children in foster care and each parent must affirm that they are the biological or adoptive parent of the child
- Allergy to fish
- Bleeding disorder, current use of anticoagulant or anti-platelet therapy, or recent or planned surgery
- Any major medical illness that interferes with regular school attendance
- Current or recent (past six months) use of omega-3 fatty acid
- Siblings with ASD
Trial locations and contacts
1 site in 1 country.
United States1 site
This study is open to continental USA
Multiple Locations, Maryland, 21205
About this study
Official title: Effectiveness of Omega-3 Fatty Acids for the Reduction of Hyperactivity in Children With Autism Spectrum Disorder
The proposed study is an internet-based, randomized, double-blind, placebo-controlled trial which will assess changes in hyperactivity in children ages five through eight with an autism spectrum disorders (ASD) and elevated levels of hyperactivity. In order to answer this question, this study will assess changes in hyperactivity as measured by the Aberrant Behavior Checklist (ABC) in children with ASD and elevated baseline levels of hyperactivity who are randomly assigned to use 1.3 grams of omega-3 fatty acids daily compared to placebo. The overwhelming majority of study procedures, including recruitment, informed consent, assessment of inclusion and exclusion criteria, and collection of baseline and outcome measures will take place over the internet.
Read the detailed description
Families and caregivers of children enrolled in the IAN Research between the age 5-8 and with an established diagnosis of autism will be invited to participate in the study by e-mail. All of these families have previously given consent to be contacted about research opportunities. Families who respond to the e-mail recruitment letter will undergo a brief screening process to determine if the child has any exclusion criteria and to ensure the child is age 5-8, has an autism spectrum disorder, and has elevated baseline levels of hyperactivity. Families will undergo an on-line informed consent process including assent of the child. All participants will be given an opportunity to speak with a study team member should they have any questions about the study or the informed consent process. Participants will sign the informed consent using an electronic signature, a process that has been used previously in the IAN network and approved by the John's Hopkins Institutional Review Board (IRB). Families meeting all eligibility criteria will be randomly assigned and mailed the study medication (omega-3 or placebo) which will be administered to children by the parents twice daily for six weeks. Both the study medication and the matching placebo are an orange-flavored pudding that is specifically designed to be palatable for young children. Assessment of child hyperactivity, social functioning, and overall disease severity will be measured at baseline, three and six weeks by the parents, who will complete on-line standard questionnaires; ABC, Social Responsiveness Scale (SRS), clinical Global Impressions Scale (CGI).
Side effects will be assessed every week by e-mail, and any report of a side effect will immediately be followed-up with telephone contact from the PI. Although omega-3 fatty acids are extremely safe in the prescribed doses, the PI or another study physician will still be on call 24-hours-a-day, 7-days-a-week to speak to participants about possible adverse events or new medical problems (all enrolled families are provided with this 24-hour emergency phone contact information).
As part of the weekly e-mail reminder, parents will also be asked to log the medication that was provided to their children each day of the previous week to measure medication adherence.
- Conditions
- Autism Spectrum Disorders, Hyperactivity
- Being tested
- Omega-3 Fatty Acids, Placebo
- Medical subject headings
- Autism Spectrum Disorder, Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 Fatty AcidsDrug
Also called Omega-3, N-3 Fatty Acid
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).
PlaceboOther
Placebo packets will have same orange-flavored pudding as active Omega-3 fatty acids comparator with an identical appearance and taste, but will include safflower oil instead of the fish oil. One placebo packet will be given twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 Fatty Acids | Active comparator | 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 Receives: Drug: Omega-3 Fatty Acids |
| Placebo | Placebo comparator | Placebo packets will have same orange-flavored pudding with an identical appearance and taste, but will include safflower oil instead of the fish oil. One placebo packet will be given twice daily. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Aberrant Behavior Checklist - Hyperactivity Subscale (ABC-H) Score
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.
Measured: Baseline, 6 weeks (3 week value to be collected)
Secondary outcomes (6)
Change in Aberrant Behavior Checklist - Lethargy Subscale Score
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.
Measured: Baseline, Week 6
Change in Aberrant Behavior Checklist - Stereotypy Subscale Score
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.
Measured: Baseline, Week 6
Aberrant Behavior Checklist - Irritability Subscale Score
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.
Measured: Baseline, Week 6
Aberrant Behavior Checklist - Inappropriate Speech Subscale Score
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.
Measured: Baseline, Week 6
Change in Social Responsiveness Scale (SRS) Score
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.
A total Total-score of 76 or higher is considered severe and strongly associated with a clinical diagnosis of Autistic Disorder. T-scores of 66 through 75 are interpreted as indicating Moderate deficiencies in reciprocal social behavior that are clinically significant and lead to substantial interference in everyday social interactions, whereas T-scores of 60 to 65 are in the Mild range and indicate mild to moderate deficits in social interaction. T scores of 59 and below are considered to be within typical limits and generally not associated with clinically significant ASD.
Measured: Baseline, Week 6
Change in Clinical Global Impression - Improvement (CGI-I) Score
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.
Measured: Baseline, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Paul A Law, M.D., Principal investigator, Kennedy Krieger Institute and Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694667
- Sponsor's protocol ID
- NA_00068694
- Status last verified
- Aug 2020
- First submitted
- 26 Mar 2012
- Last updated
- 31 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Bent S, Hendren RL, Zandi T, Law K, Choi JE, Widjaja F, Kalb L, Nestle J, Law P. Internet-based, randomized, controlled trial of omega-3 fatty acids for hyperactivity in autism. J Am Acad Child Adolesc Psychiatry. 2014 Jun;53(6):658-66. doi: 10.1016/j.jaac.2014.01.018. Epub 2014 Mar 12.
PubMed 24839884
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Omega-3 Fatty Acids for the Reduction of Hyperactivity in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT01694667
- Acronym / sponsor ID
- NA_00068694
- Conditions
- Autism Spectrum Disorders, Hyperactivity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.University, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- Sep 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 27 Sep 2012 (estimated)
- Results
- Posted 16 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study is an internet-based, randomized, double-blind, placebo-controlled trial which will assess changes in hyperactivity in children ages five through eight with an autism spectrum disorders (ASD) and elevated levels of hyperactivity. In order to answer this question, this study will assess changes in hyperactivity as measured by the Aberrant Behavior Checklist (ABC) in children with ASD and elevated baseline levels of hyperactivity who are randomly assigned to use 1.3 grams of omega-3 fatty acids daily compared to placebo. The overwhelming majority of study procedures, including recruitment, informed consent, assessment of inclusion and exclusion criteria, and collection of baseline and outcome measures will take place over the internet.
Detailed description
Families and caregivers of children enrolled in the IAN Research between the age 5-8 and with an established diagnosis of autism will be invited to participate in the study by e-mail. All of these families have previously given consent to be contacted about research opportunities. Families who respond to the e-mail recruitment letter will undergo a brief screening process to determine if the child has any exclusion criteria and to ensure the child is age 5-8, has an autism spectrum disorder, and has elevated baseline levels of hyperactivity. Families will undergo an on-line informed consent process including assent of the child. All participants will be given an opportunity to speak with a study team member should they have any questions about the study or the informed consent process. Participants will sign the informed consent using an electronic signature, a process that has been used previously in the IAN network and approved by the John's Hopkins Institutional Review Board (IRB). Families meeting all eligibility criteria will be randomly assigned and mailed the study medication (omega-3 or placebo) which will be administered to children by the parents twice daily for six weeks. Both the study medication and the matching placebo are an orange-flavored pudding that is specifically designed to be palatable for young children. Assessment of child hyperactivity, social functioning, and overall disease severity will be measured at baseline, three and six weeks by the parents, who will complete on-line standard questionnaires; ABC, Social Responsiveness Scale (SRS), clinical Global Impressions Scale (CGI).
Side effects will be assessed every week by e-mail, and any report of a side effect will immediately be followed-up with telephone contact from the PI. Although omega-3 fatty acids are extremely safe in the prescribed doses, the PI or another study physician will still be on call 24-hours-a-day, 7-days-a-week to speak to participants about possible adverse events or new medical problems (all enrolled families are provided with this 24-hour emergency phone contact information).
As part of the weekly e-mail reminder, parents will also be asked to log the medication that was provided to their children each day of the previous week to measure medication adherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3 Fatty Acids | Active comparator | Drug: Omega-3 Fatty AcidsOmega-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 |
| Placebo | Placebo comparator | Other: PlaceboPlacebo packets will have same orange-flavored pudding with an identical appearance and taste, but will include safflower oil instead of the fish oil. One placebo packet will be given twice daily. |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children who are participating in Interactive Autism Network (IAN) Research Families
- Diagnosis of (Autism Spectrum Disorders (ASD) by a professional and Social Communication Question (SCQ) score>12
- Age 5-8
- Aberrant Behavior Checklist - Hyperactivity subscale (ABC-H)>20
Key exclusion criteria (6 listed)
- Children in foster care and each parent must affirm that they are the biological or adoptive parent of the child
- Allergy to fish
- Bleeding disorder, current use of anticoagulant or anti-platelet therapy, or recent or planned surgery
- Any major medical illness that interferes with regular school attendance
- Current or recent (past six months) use of omega-3 fatty acid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 Fatty AcidsAlso: Omega-3, N-3 Fatty AcidOmega-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). | Drug | Omega-3 Fatty Acids |
| PlaceboPlacebo packets will have same orange-flavored pudding as active Omega-3 fatty acids comparator with an identical appearance and taste, but will include safflower oil instead of the fish oil. One placebo packet will be given twice daily. | Other | Placebo |
Primary outcome
Change in Aberrant Behavior Checklist - Hyperactivity Subscale (ABC-H) Score
Time frame: Baseline, 6 weeks (3 week value to be collected)
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.
6 secondary outcomes
Change in Aberrant Behavior Checklist - Lethargy Subscale Score
Time frame: Baseline, Week 6
Change in Aberrant Behavior Checklist - Stereotypy Subscale Score
Time frame: Baseline, Week 6
Aberrant Behavior Checklist - Irritability Subscale Score
Time frame: Baseline, Week 6
Aberrant Behavior Checklist - Inappropriate Speech Subscale Score
Time frame: Baseline, Week 6
Change in Social Responsiveness Scale (SRS) Score
Time frame: Baseline, Week 6
Change in Clinical Global Impression - Improvement (CGI-I) Score
Time frame: Baseline, Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24839884Bent S, Hendren RL, Zandi T, Law K, Choi JE, Widjaja F, Kalb L, Nestle J, Law P. Internet-based, randomized, controlled trial of omega-3 fatty acids for hyperactivity in autism. J Am Acad Child Adolesc Psychiatry. 2014 Jun;53(6):658-66. doi: 10.1016/j.jaac.2014.01.018. Epub 2014 Mar 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul A Law, M.D. principal investigator
Kennedy Krieger Institute and Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omega-3 Fatty Acids in people with Autism Spectrum Disorders and Hyperactivity, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Aberrant Behavior Checklist - Hyperactivity Subscale (ABC-H) Score (time frame: Baseline, 6 weeks (3 week value to be collected)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01694667, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2020.