Feasibility of Omega-3 Supplementation for Children With Language Impairments

NCT01640106 | Terminated

• 1 other identifier: 09-164-PED
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Language Impairment

Keywords

Language; Fatty acids; Nutrition; Developmental delay

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Feasibility of fish oil vs. chewable Concordix paste

  Given for 3 months as intervention

Study Arms (2)

Omega-3

EXPERIMENTAL

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

Dietary Supplement: Omega-3

Control

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Omega-3 DIETARY_SUPPLEMENT

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

Also known as: Concordix chewable paste

Omega-3

Placebo DIETARY_SUPPLEMENT

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

Control

Eligibility Criteria

• Age: 24 Months - 42 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Shuvo Ghosh: lead

Study Sites (1)

McGill University/Montreal Children's Hospital

Montreal, Quebec, H3H 1P3, Canada

Location

MeSH Terms

Conditions

Language Disorders; Language; Learning Disabilities

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Communication; Behavior; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Shuvo Ghosh, MD

  MUHC Montreal Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: June 26, 2012
• First Posted: July 13, 2012
• Study Start: June 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: June 1, 2015
• Last Updated: September 9, 2019

Record last verified: 2019-09

Locations

CA (1)