Could a fish oil supplement help kids with speech apraxia?
NCT ID NCT07216001
First seen Jun 27, 2026 · Last updated Jul 30, 2026 · Updated 2 times
Summary
This study tests an investigational drug called Omega-DEK plus L-carnitine in 34 children aged 3 to 6 with childhood apraxia of speech (CAS). The study lasts 20 weeks and first gives everyone the treatment, then randomly assigns some to a placebo to see if the treatment helps maintain speech gains. The main goal is to see if this approach is feasible and acceptable for families.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 34 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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36 months to 6 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria for Main Trial: 1. Confirmed diagnosis of childhood apraxia of speech/verbal apraxia by a qualified professional (SLP) based on established guidelines 2. Male and female, age 36 months - 6 years (inclusive) 3. Ability to comprehend and use Standard American English Exclusion Criteria for Main Trial: 1. Children unable to tolerate oral supplementation 2. Known allergy to fish oil, palm kernel oil or other ingredients in investigational drug 3. Medical or genetic condition that in the opinion of the PI/Co-Is may affect participation and compromise results (including significant receptive language delay, moderate-severe cognitive delay, complex medical history, hearing loss, cerebral palsy, history of traumatic brain injury or severe anoxic event, Down's syndrome) 4. Known seizure disorder or history of febrile seizures 5. History of cardiac dysrhythmia or abnormal ECG at baseline 6. A prothrombin time test with an international normalised ratio (PT/INR) \>1.2 7. Use of blood thinners, including chronic aspirin, chronic NSAIDS, warfarin etc. 8. A history of PUFA or vit E supplementation use within 3 months prior to enrollment in the study 9. On an elimination diet for \< 3 months (gluten, casein, yeast free etc.) prior to enrollment, or planning to initiate a special diet during the study 10. Recent reintroduction of food items from elimination diet \< 3 months 11. On any additional nutritional interventions/supplements \< 3 months (i.e. high dose vitamins/minerals that exceed what would be found in a children's multivitamin supplement etc., probiotics) 12. Any new chronic medication \< 3 months prior to enrollment (stable doses \> 3 months allowed; medications for acute illness allowed including antipyretics, antibiotics, asthma medication) 13. Anticipated initiation of new chronic medication during study timeline including new attention-deficit/hyperactivity disorder (ADHD) medications, other behavior medications 14. Plans to try additional complementary interventions or diets during the study period 15. Planned surgery during or within 4 weeks after conclusion of trial Inclusion Criteria for Expanded Cohort: 1. Working Diagnosis of CAS, or intestinal lymphangiectasia, or fat malabsorption syndrome (in isolation or associated with other medical conditions such as cystic fibrosis, celiac disease, etc.) 2. Male and female, aged ≥2 years 3. Ability to comprehend and use Standard American English Exclusion Criteria for Expanded Cohort: 1. Subjects unable to tolerate oral supplementation 2. Known allergy to fish oil, palm kernel oil or other ingredients in investigational drug 3. History of cardiac dysrhythmia or abnormal ECG at baseline 4. PT-INR \>1.2. A clinical lab performed within a month of enrollment will be accepted to meet this exclusion criteria 5. Use of blood thinners, including chronic aspirin, chronic NSAIDS, warfarin etc. (Symptomatic use of NSAIDS for acute fever or pain permitted)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Children's Healthcare of Atlanta
Atlanta, Georgia, 30322, United States
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Marcus Autism Center
Atlanta, Georgia, 30329, United States
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