Trial · NCT00467818
Omega 3 Fatty Acids in the Treatment of Children With Autism Spectrum Disorders
NCT00467818, Not applicable, Completed, University of Medicine and Dentistry of New Jersey; results first posted 2020-12-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Omega 3 Fatty Acids in the Treatment of Children With Autism Spectrum Disorders. Trials, record NCT00467818. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00467818
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Omega 3 Fatty Acids in the Treatment of Children With Autism Spectrum Disorders
- NCT number
- NCT00467818
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 17 participants, actual
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Conditions
- Autism
- Interventions
- Omega 3 fatty acids, Placebo
- First posted
- 2007-05-01
- Last updated
- 2021-01-26
- Results first posted
- 2020-12-16
- Limitations and caveats
One subject had a recurrence of a psychiatric issue ( although might be unrelated to the intake of the placebo which he was on) which lead to hospitalisation and discontinuation of taking the placebo and subsequent withdrawal from the study.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Global Impression Scale(CGI)- Improvement | Administered biweekly, endpoint score (week 12) only used for data analysis | This scale measures the impression of improvement as assessed from interviewing the subject and informant.The scale is measured with numbers from 0 through 7 with 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. Units = scores on a scale. |
| Primary | Aberrant Behavior Checklist (ABC) | Administered every 4 weeks, 12 week scores used for means, score on irritability subscale reported | Aberrant Behavior Checklist (ABC)-Community Version (Irritability Subscale) (Aman et al. 1985). It is designed to objectively identify five behavior subscales through observation by the primary caregiver. The five behavior subscales include (ranges show no problem to severe problem): irritability (range 0-45), lethargy (range 0-48), stereotypy (range 0-21), hyperactivity range 0-48), and inappropriate speech (range 0-12), all possible signs and symptoms of affective instability in autistic individuals (Lainhart \& Folstein, 1994). Improvement is shown with scores decreasing over time. Total score is not used. Inter-rater reliability for the ABC-CV is moderate to high across subscales with a mean of .63. Test-retest reliability correlations are .98 -Irritability, .99 -Lethargy, .98 -Stereotypy, .98 -Hyperactivity, and .96 -Inappropriate Speech. The ABC will be filled out by an informant (teacher/parent), and then reviewed by the IE. Administration time is approximately 10 minutes. |
| Primary | Vineland Adaptive Behavior Scale | Administered during the baseline visit and on week 12 ( termination) | The Vineland Scale is a semi-structured informant interview that assesses subjects' functioning. It is administered to a caretaker/family member. The scale has been revised and standardized in all populations. This scale has been found to assess social deficits in autism and strengths in daily living skills. Items are classified under four major adaptive domains: communication, daily living skills, socialization and motor skills. The items are scored 0-2 (yes/sometimes/never). Each domain is summed, and the domain scores are converted to standardized scores. The normative score is 100, with standard deviation of 15. The standardized score is used in this study. A higher score (above 100) means better adaptive behavior. Minimum value is 0, maximum value is infinity. |
| Secondary | Overt Aggression Scale-Modified | Administered biweekly and at week 12 (termination) | The Modified version, Coccaro et al. is designed for outpatient use and assessment of behavior over one week. This scale was assessed biweekly. The OAS-M consists of 3 domains: Aggression, Irritability, and Suicidality (not used). Aggression Domain: 4 subscales of weighted behavior: Verbal Aggression (1), Aggression Against Objects (2), Aggression Against Others (3), and Self-Aggression (4). Within each category, severity of an event receives a scaled score (0-5) (higher score for worse behaviors) which is then multiplied by the weekly frequency of this event and weight, then totaled (for use in this study). Irritability subscale is divided into subjective/objective, 0 (low)-5 (high). The total scale has a minimum value of 0 (no display of aggressive/irritable behavior) and a maximum value of infinity (worse aggressive/irritable behavior) as reporting the number of times an aggressive/irritable behavior occurred does not have a maximum value). Higher scores mean worse outcome. |
| Secondary | Parental Stress Index | Administered during the baseline visit and on week 12 ( termination) | This measurement assesses child and parental characteristics and parent-child relationship dimensions associated with the presence of parenting stress/ troubled relationships. It is a self-report scale completed by the parent, consisting of 101 items organized into two domains with the following subscales: (1) child characteristics domain - adaptability, demandingness, mood, distractibility/hyperactivity, acceptability of child to parent, and child's reinforcement of parent, and (2) parent characteristics domain - depression, attachment to child, social isolation, sense of competence in the parenting role, relationship with spouse/parenting partner, role restrictions, and parental health. Scores are 1-5 with 1 being strongly agree and 5 being strongly disagree. Scores are collected and standardized. The higher a score is, the more stress a parent is experiencing. Minimum value is 101 and maximum value is 505. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Global Impression Scale(CGI)- Improvement | Administered biweekly, endpoint score (week 12) only used for data analysis | units on a scale | MEAN | |
| PRIMARY | Aberrant Behavior Checklist (ABC) | Administered every 4 weeks, 12 week scores used for means, score on irritability subscale reported | Youth and adolescents ages 5-17 with autism spectrum disorder | units on a scale | MEAN |
| PRIMARY | Vineland Adaptive Behavior Scale | Administered during the baseline visit and on week 12 ( termination) | units on a scale | MEAN | |
| SECONDARY | Overt Aggression Scale-Modified | Administered biweekly and at week 12 (termination) | units on a scale | MEAN | |
| SECONDARY | Parental Stress Index | Administered during the baseline visit and on week 12 ( termination) | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Global Impression Scale(CGI)- Improvement | Omega 3 Fatty Acids, Drug | 3.57 | Standard Deviation 1.2 | units on a scale | |
| Clinical Global Impression Scale(CGI)- Improvement | Placebo | 3.8 | Standard Deviation 1.2 | units on a scale | |
| Aberrant Behavior Checklist (ABC) | Omega 3 Fatty Acids, Drug | 5.66 | Standard Deviation 5.0 | units on a scale | |
| Aberrant Behavior Checklist (ABC) | Placebo | 8.5 | Standard Deviation 2.1 | units on a scale | |
| Vineland Adaptive Behavior Scale | Omega 3 Fatty Acids, Drug | 51.5 | Standard Deviation 13.28 | units on a scale | |
| Vineland Adaptive Behavior Scale | Placebo | 27.5 | Standard Deviation 9.81 | units on a scale | |
| Overt Aggression Scale-Modified | Omega 3 Fatty Acids, Drug | 3.8 | Standard Deviation 2.7 | units on a scale | |
| Overt Aggression Scale-Modified | Placebo | 2.4 | Standard Deviation 2.6 | units on a scale | |
| Parental Stress Index | Omega 3 Fatty Acids, Drug | 314.2 | Standard Deviation 35.2 | units on a scale | |
| Parental Stress Index | Placebo | 279.5 | Standard Deviation 35.4 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Omega 3 Fatty Acids, Drug | 9 | |
| Overall Study | STARTED | Placebo | 8 | |
| Overall Study | COMPLETED | Omega 3 Fatty Acids, Drug | 6 | |
| Overall Study | COMPLETED | Placebo | 6 | |
| Overall Study | NOT COMPLETED | Omega 3 Fatty Acids, Drug | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 2 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Recurrence of mood disorder in one participant | Psychiatric disorders | Omega 3 Fatty Acids, Drug | 0 | 9 | 0 |
| serious | Recurrence of mood disorder in one participant | Psychiatric disorders | Placebo | 1 | 8 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Omega 3 Fatty Acids, Drug | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Omega 3 Fatty Acids, Drug | 0 | 9 |
| Total, other adverse events | Placebo | 0 | 8 |
| Total, serious adverse events | Omega 3 Fatty Acids, Drug | 0 | 9 |
| Total, serious adverse events | Placebo | 1 | 8 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R21AT002927 | Omega 3 Fatty Acids in the Treatment of Children with Autism Spectrum Disorders | NOVOTNY, SHERIE L | UNIV OF MED/DENT NJ-R W JOHNSON MED SCH | NATIONAL CENTER FOR COMPLEMENTARY & INTEGRATIVE HEALTH | 2006 to 2008 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Omega 3 Fatty Acids, Drug vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00467818
GET https://conductscience.org/api/trials/v1/NCT00467818/registered