Feasibility of Omega-3 Supplementation for Children With Language Impairments

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01640106
Recruitment Status : Unknown
Verified July 2012 by McGill University Health Center.
Recruitment status was:  Recruiting
First Posted : July 13, 2012
Last Update Posted : July 13, 2012
Information provided by (Responsible Party):
McGill University Health Center

Brief Summary:
The primary objective of this study is to obtain preliminary (pilot) data regarding the feasibility of using dietary omega-3 supplementation in children with significant delays in language skills; a related secondary objective is to compare adherence to a dosage schedule of two easy-to-take formulations. A tertiary objective of this study is to collect preliminary (pilot) data pre- and post-supplementation to identify potential improvement of skills in a specific area of language development.

Condition or disease Intervention/treatment Phase
Language Impairment Dietary Supplement: Omega-3 Dietary Supplement: Placebo Phase 3

Detailed Description:
HYPOTHESIS Hypothesis 1: Children with early developmental impairment in language will successfully take daily omega-3 fatty acid supplementation for a well-defined period of time (3 months); Hypothesis 2: Children with early developmental impairment will better adhere to administration of a small quantity of slightly fishy-tasting oil than to a large quantity of sweet-tasting paste; Hypothesis 3: A 3 month period of daily omega-3 supplementation will produce some improvement in fast-mapping language skills (a dynamic vocabulary learning skill that has been shown to rapidly improve after exposure to beneficial intervention).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Feasibility of Omega-3 Fatty Acid Supplementation for Children With Early Developmental Impairment in Language
Study Start Date : June 2012
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Omega-3
Treatment arm, using the omega-3 product (fish oil/paste)
Dietary Supplement: Omega-3
800 mg Omega 3 daily (600 mg DHA/200 mg EPA)
Other Name: Concordix chewable paste

Placebo Comparator: Control Dietary Supplement: Placebo

Primary Outcome Measures :
  1. Change over 3 months in learning assessed by a fast-mapping task [ Time Frame: Assessed at time of diagnosis and 3 months after intervention ]
    A simple "fast-mapping" task, which is a measure of language learning used widely in linguistics research, will be performed in the pre and post-intervention period. We will present a list of non-words selected with only early-developing sounds to ensure that they are within the repertoire of developmentally impaired children. Scores are calculated in terms of number of items successfully completed. An initial and final assessment of dynamic language learning will be done as an addendum to scores on standardized language tests that establish a language impairment diagnosis.

Secondary Outcome Measures :
  1. Feasibility of fish oil vs. chewable Concordix paste [ Time Frame: Given for 3 months as intervention ]
    In order to estimate the relative success of administering paste vs. oil in relation to omega-3 vs. placebo, a repeated measures ANOVA will be used to test for significant differences. The primary measure will be parental report as "easy" vs. "difficult" to administer, and the analysis will be run as Between group (paste vs. oil) by Treatment arm (omega-3 vs. placebo) by Adminstration success (easy vs. difficult).

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Ages Eligible for Study:   24 Months to 42 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • children in the chronological age range of 24 to 42 months at the time of initial assessment
  • diagnosis of expressive, receptive or mixed language impairment (LI) by a certified Speech-Language Pathologist (S-LP)
  • ability to take daily omega-3 supplementation (with caregiver assistance)

Exclusion Criteria:

  • children with any organic disease processes or genetic syndromes, or known developmental disorders such as autism that may present with language impairment
  • children with hearing impairment
  • children who take any non-standard dietary supplements (i.e., apart from multi-vitamins), particularly any omega-3 FA, prior to starting the study
  • children whose parents do not have an adequate understanding of English or French

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01640106

Contact: Shuvo Ghosh, MD 514-412-4400 ext 23072
Contact: Jennifer Frei, BA 514-412-4400 ext 22934

Canada, Quebec
McGill University/Montreal Children's Hospital Recruiting
Montreal, Quebec, Canada, H3H 1P3
Sponsors and Collaborators
McGill University Health Center
Principal Investigator: Shuvo Ghosh, MD MUHC Montreal Children's Hospital

Responsible Party: McGill University Health Center Identifier: NCT01640106     History of Changes
Other Study ID Numbers: 09-164-PED
First Posted: July 13, 2012    Key Record Dates
Last Update Posted: July 13, 2012
Last Verified: July 2012

Keywords provided by McGill University Health Center:
Fatty acids
Developmental delay

Additional relevant MeSH terms:
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms