Back to resultsFeasibility of Omega-3 Supplementation for Children With Language Impairments
Primary Purpose
Language Impairment
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Omega-3
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Language Impairment focused on measuring Language, Fatty acids, Nutrition, Developmental delay
Eligibility Criteria
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
Sites / Locations
- McGill University/Montreal Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Omega-3
Control
Arm Description
Treatment arm, using the omega-3 product (fish oil/paste)
Placebo is a paste of non-omega-3 (plant based) oil with a taste/flavour identical to intervention paste
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01640106
Brief Title
Feasibility of Omega-3 Supplementation for Children With Language Impairments
Official Title
Feasibility of Omega-3 Fatty Acid Supplementation for Children With Early Developmental Impairment in Language
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
Recruitment very difficult; only preliminary data usable.
Study Start Date
June 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shuvo Ghosh
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Language Impairment
Keywords
Language, Fatty acids, Nutrition, Developmental delay
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omega-3
Arm Type
Experimental
Arm Description
Treatment arm, using the omega-3 product (fish oil/paste)
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo is a paste of non-omega-3 (plant based) oil with a taste/flavour identical to intervention paste
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3
Other Intervention Name(s)
Concordix chewable paste
Intervention Description
800 mg Omega 3 daily (600 mg DHA/200 mg EPA)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo is a combination of dietary plant-based oils in a paste containing no Omega-3 (EPA or DHA)
Primary Outcome Measure Information:
Title
Change over 3 months in learning assessed by a fast-mapping task
Description
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.
Time Frame
Assessed at time of diagnosis and 3 months after intervention
Secondary Outcome Measure Information:
Title
Feasibility of fish oil vs. chewable Concordix paste
Description
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).
Time Frame
Given for 3 months as intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
42 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuvo Ghosh, MD
Organizational Affiliation
MUHC Montreal Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill University/Montreal Children's Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1P3
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Feasibility of Omega-3 Supplementation for Children With Language Impairments
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