Feasibility of Omega-3 Supplementation for Children With Language Impairments

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Language Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Omega-3

Treatment arm, using the omega-3 product (fish oil/paste)

Group Type EXPERIMENTAL

Omega-3

Intervention Type DIETARY_SUPPLEMENT

800 mg Omega 3 daily (600 mg DHA/200 mg EPA)

Control

Placebo is a paste of non-omega-3 (plant based) oil with a taste/flavour identical to intervention paste

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo is a combination of dietary plant-based oils in a paste containing no Omega-3 (EPA or DHA)

Interventions

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Omega-3

800 mg Omega 3 daily (600 mg DHA/200 mg EPA)

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo is a combination of dietary plant-based oils in a paste containing no Omega-3 (EPA or DHA)

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Concordix chewable paste

Eligibility Criteria

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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

Minimum Eligible Age

24 Months

Maximum Eligible Age

42 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No