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Maternal Polyunsaturated Fatty Acids in Association With Child Autism Spectrum Disorder in the MARBLES Study

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ClinicalTrials.gov Identifier: NCT03468959
Recruitment Status : Completed
First Posted : March 19, 2018
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Autism Spectrum Disorder Behavioral: Maternal Supplemental PUFA Intake

Study Design
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Study Type : Observational
Actual Enrollment : 252 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Maternal Polyunsaturated Fatty Acids in Association With Child Autism Spectrum Disorder in the MARBLES Study
Actual Study Start Date : January 2006
Actual Primary Completion Date : June 30, 2016
Actual Study Completion Date : June 30, 2016

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Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Behavioral: Maternal Supplemental PUFA Intake
Maternal Supplemental PUFA Intake included sources from the questionnaires and plasma


Outcome Measures
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Primary Outcome Measures :
  1. autism spectrum disorder group (ASD) [ Time Frame: 36 months ]
    number of people with ASD


Secondary Outcome Measures :
  1. A group of typically development (TD) people [ Time Frame: 36 months ]
    number of typically developed people


Other Outcome Measures:
  1. A group of non-typical development (Non-TD) people [ Time Frame: 36 months ]
    number of people with non-typical development


Eligibility Criteria
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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Mothers with diseases which will influence on their study participation
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03468959    
Other Study ID Numbers: 225645
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders