Autism Spectrum DisorderNCT03468959
Maternal Polyunsaturated Fatty Acids in Association With Child Autism Spectrum Disorder in the MARBLES Study
An observational study of Autism Spectrum Disorder, run by University of California, Davis.
Trial summary
This study is to examine the association between maternal omega3 and other polyunsaturated fatty acids (PUFAs) during pregnancy and autism spectrum disorder (ASD) as well as other non-typical development (Non-TD) in the prospective Markers of Autism Risk in Babies-Learning Early Signs (MARBLES) cohort. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Maternal Supplemental PUFA Intake
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 252 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to 30 Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Families were recruited from lists of children receiving autism services obtained via the California Department of Developmental Services (DDS), from other studies at the Medical Investigation of Neurodevelopmental Disorders (MIND) Institute, or by self-referrals.
Who may be able to join
- Mother or father had a biological child with ASD
- Mother is at least 18 years old
- Mother is pregnant or planning a pregnancy, and biologically able to become pregnant
- Mother is living within 2 hours of the MIND Institute
- Mother is sufficiently fluent in English
Who cannot join
- Mothers with diseases which will influence on their study participation
About this study
This study is to examine the association between maternal omega3 and other polyunsaturated fatty acids (PUFAs) during pregnancy and autism spectrum disorder (ASD) as well as other non-typical development (Non-TD) in the prospective Markers of Autism Risk in Babies-Learning Early Signs (MARBLES) cohort.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Maternal Supplemental PUFA Intake
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal Supplemental PUFA IntakeBehavioural
Maternal Supplemental PUFA Intake included sources from the questionnaires and plasma
| Study group | Role | What they receive |
|---|---|---|
| Mother-child pairs | Families were recruited from lists of children receiving autism services obtained via the California Department of Developmental Services (DDS), from other studies at the Medical Investigation of Neurodevelopmental Disorders (MIND) Institute, or by self-referrals. The inclusion criteria were: a) mother or father had a biological child with ASD, and the mother was b) at least 18 years old; c) pregnant or planning a pregnancy, and biologically able to become pregnant; d) living within 2 hours of the MIND Institute; e) sufficiently fluent in English. Receives: Behavioral: Maternal Supplemental PUFA Intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
autism spectrum disorder group (ASD)
number of people with ASD
Measured: 36 months
Secondary outcomes (1)
A group of typically development (TD) people
number of typically developed people
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study startJan 2006
- Primary completion30 Jun 2016
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468959
- Sponsor's protocol ID
- 225645
- Status last verified
- Feb 2018
- First submitted
- 9 Feb 2018
- Last updated
- 29 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Polyunsaturated Fatty Acids in Association With Child Autism Spectrum Disorder in the MARBLES Study
- ClinicalTrials.gov ID
- NCT03468959
- Acronym / sponsor ID
- 225645
- Conditions
- Autism Spectrum Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Jan 2006 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 19 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to examine the association between maternal omega3 and other polyunsaturated fatty acids (PUFAs) during pregnancy and autism spectrum disorder (ASD) as well as other non-typical development (Non-TD) in the prospective Markers of Autism Risk in Babies-Learning Early Signs (MARBLES) cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mother-child pairs | – | Behavioral: Maternal Supplemental PUFA IntakeFamilies were recruited from lists of children receiving autism services obtained via the California Department of Developmental Services (DDS), from other studies at the Medical Investigation of Neurodevelopmental Disorders (MIND) Institute, or by self-referrals. The inclusion criteria were: a) mother or father had a biological child with ASD, and the mother was b) at least 18 years old; c) pregnant or planning a pregnancy, and biologically able to become pregnant; d) living within 2 hours of the MIND Institute; e) sufficiently fluent in English. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Families were recruited from lists of children receiving autism services obtained via the California Department of Developmental Services (DDS), from other studies at the Medical Investigation of Neurodevelopmental Disorders (MIND) Institute, or by self-referrals.
Key inclusion criteria (5 listed)
- Mother or father had a biological child with ASD
- Mother is at least 18 years old
- Mother is pregnant or planning a pregnancy, and biologically able to become pregnant
- Mother is living within 2 hours of the MIND Institute
- Mother is sufficiently fluent in English
Key exclusion criteria (1 listed)
- Mothers with diseases which will influence on their study participation
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 |
|---|---|---|
| Maternal Supplemental PUFA IntakeMaternal Supplemental PUFA Intake included sources from the questionnaires and plasma | Behavioural | Mother-child pairs |
Primary outcome
autism spectrum disorder group (ASD)
Time frame: 36 months
number of people with ASD
1 secondary outcome
A group of typically development (TD) people
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by University of California, Davis.
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 5 inclusion and 1 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 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
autism spectrum disorder group (ASD) (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Dec 2023.