Status:
NOT_YET_RECRUITING
Role of Omega-DEK in Childhood Apraxia of Speech
Lead Sponsor:
Claudia R. Morris
Conditions:
Childhood Apraxia of Speech
Verbal Apraxia
Eligibility:
All Genders
36-6 years
Phase:
PHASE2
Brief Summary
This is a 20-week study for children between 3 and 6 years old with confirmed childhood apraxia of speech (CAS). The study includes a 12-week open-label pilot feasibility study of an investigational d...
Detailed Description
Verbal apraxia (VA) is a severe neurological motor planning speech disorder of unknown etiology. It is a devastating disorder that is insufficiently recognized by general pediatricians and often goes ...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of childhood apraxia of speech/verbal apraxia by a qualified professional (SLP) based on established guidelines.
- Male and female, age 36 months - 6 years (inclusive)
- Ability to comprehend and use Standard American English
Exclusion
- Children unable to tolerate oral supplementation
- Known allergy to fish oil, palm kernel oil or other ingredients in investigational drug
- 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).
- Known seizure disorder or history of febrile seizures
- History of cardiac dysrhythmia or abnormal ECG at baseline
- A prothrombin time test with an international normalised ratio (PT/INR) \>1.2.
- Use of blood thinners, including chronic aspirin, chronic NSAIDS, warfarin etc.
- A history of PUFA or vit E supplementation use within 3 months prior to enrollment in the study
- 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
- Recent reintroduction of food items from elimination diet \< 3 months
- 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)
- Any new chronic medication \< 3 months prior to enrollment (stable doses \> 3 months allowed; medications for acute illness allowed including antipyretics, antibiotics, asthma medication)
- Anticipated initiation of new chronic medication during study timeline including new attention-deficit/hyperactivity disorder (ADHD) medications, other behavior medications
- Plans to try additional complementary interventions or diets during the study period
- Planned surgery during or within 4 weeks after conclusion of trial
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT07216001
Start Date
November 1 2025
End Date
July 1 2027
Last Update
October 14 2025
Active Locations (2)
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1
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
2
Marcus Autism Center
Atlanta, Georgia, United States, 30329