Language ImpairmentNCT01640106
Feasibility of Omega-3 Supplementation for Children With Language Impairments
A study testing Omega-3 in people with Language Impairment, run by Shuvo Ghosh at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 42 months
- Conditions the study is for
- Language Impairment
- What is being tested?
- Omega-3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2012to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 42 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
McGill University/Montreal Children's Hospital
Montreal, Quebec, H3H 1P3
About this study
Official title: 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.
Read the 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).
- Conditions
- Language Impairment
- Being tested
- Omega-3, Placebo
- Keywords
- Language, Fatty acids, Nutrition, Developmental delay
- Medical subject headings
- Language Disorders, Language, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3Dietary supplement
Also called Concordix chewable paste
800 mg Omega 3 daily (600 mg DHA/200 mg EPA)
PlaceboDietary supplement
Placebo is a combination of dietary plant-based oils in a paste containing no Omega-3 (EPA or DHA)
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 | Experimental | Treatment arm, using the omega-3 product (fish oil/paste) Receives: 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 Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed at time of diagnosis and 3 months after intervention
Secondary outcomes (1)
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).
Measured: Given for 3 months as intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionMar 2014
- Study completionJun 2015
Why it stopped: Recruitment very difficult; only preliminary data usable.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Language ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shuvo Ghosh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shuvo Ghosh, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Shuvo Ghosh, MD, Principal investigator, MUHC Montreal Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640106
- Sponsor's protocol ID
- 09-164-PED
- Status last verified
- Sep 2019
- First submitted
- 26 Jun 2012
- Last updated
- 9 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Omega-3 Fatty Acid Supplementation for Children With Early Developmental Impairment in Language
- ClinicalTrials.gov ID
- NCT01640106
- Acronym / sponsor ID
- 09-164-PED
- Conditions
- Language Impairment
- Keywords
- Language, Fatty acids, Nutrition, Developmental delay
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment very difficult; only preliminary data usable.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Shuvo GhoshUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 13 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3 | Experimental | Dietary Supplement: Omega-3Treatment arm, using the omega-3 product (fish oil/paste) |
| Control | Placebo comparator | Dietary Supplement: PlaceboPlacebo is a paste of non-omega-3 (plant based) oil with a taste/flavour identical to intervention paste |
Who may qualify
- Ages
- 24 to 42 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3Also: Concordix chewable paste800 mg Omega 3 daily (600 mg DHA/200 mg EPA) | Dietary supplement | Omega-3 |
| PlaceboPlacebo is a combination of dietary plant-based oils in a paste containing no Omega-3 (EPA or DHA) | Dietary supplement | Control |
Primary outcome
Change over 3 months in learning assessed by a fast-mapping task
Time frame: Assessed at time of diagnosis and 3 months after intervention
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.
1 secondary outcome
Feasibility of fish oil vs. chewable Concordix paste
Time frame: Given for 3 months as intervention
Results and safety
The study was stopped early (reason given: Recruitment very difficult; only preliminary data usable.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shuvo Ghosh, MD principal investigator
MUHC Montreal Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 in people with Language Impairment, run by Shuvo Ghosh at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment very difficult; only preliminary data usable.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change over 3 months in learning assessed by a fast-mapping task (time frame: Assessed at time of diagnosis and 3 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2019.