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Feasibility of Omega-3 Supplementation for Children With Language Impairments

NCT01640106 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2019-09-09

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Omega-3

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

DIETARY_SUPPLEMENT

Placebo

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

Sponsors & Collaborators

  • Shuvo Ghosh

    lead OTHER

Principal Investigators

  • Shuvo Ghosh, MD · MUHC Montreal Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
24 Months
Max Age
42 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-03-31
Completion
2015-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01640106 on ClinicalTrials.gov