Feasibility of Omega-3 Supplementation for Children With Language Impairments

Feasibility of Omega-3 Fatty Acid Supplementation for Children With Early Developmental Impairment in Language

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.

Study Overview

• Status: Terminated
• Conditions: Language Impairment
• Intervention / Treatment: Dietary supplement: Omega-3; Dietary supplement: Placebo

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
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3H 1P3
      • McGill University/Montreal Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Concordix chewable paste
Placebo Comparator: Control; Placebo is a paste of non-omega-3 (plant based) oil with a taste/flavour identical to intervention paste	Dietary supplement: Placebo; Placebo is a combination of dietary plant-based oils in a paste containing no Omega-3 (EPA or DHA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change over 3 months in learning assessed by a fast-mapping task	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.	Assessed at time of diagnosis and 3 months after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of fish oil vs. chewable Concordix paste	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).	Given for 3 months as intervention

Collaborators and Investigators

• Sponsor: Shuvo Ghosh
• Investigators: Principal Investigator: Shuvo Ghosh, MD, MUHC Montreal Children's Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: June 26, 2012
• First Submitted That Met QC Criteria: July 12, 2012
• First Posted (Estimate): July 13, 2012

Study Record Updates

• Last Update Posted (Actual): September 9, 2019
• Last Update Submitted That Met QC Criteria: September 5, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Language; Nutrition; Fatty acids; Developmental delay
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Communication Disorders; Language Disorders
• Other Study ID Numbers: 09-164-PED

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided