Role of Omega-DEK in Childhood Apraxia of Speech

Prior treatment

• Known allergy to fish oil, palm kernel oil or other ingredients in investigational drug
• 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
• Any new chronic medication \< 3 months prior to enrollment (stable doses \> 3 months allowed; medications for acute illness allowed including antipyretics, antibiotics, asthma medication)
• Planned surgery during or within 4 weeks after conclusion of trial
• Known allergy to fish oil, palm kernel oil or other ingredients in investigational drug

Other illness

• 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
• Anticipated initiation of new chronic medication during study timeline including new attention-deficit/hyperactivity disorder (ADHD) medications, other behavior medications
• History of cardiac dysrhythmia or abnormal ECG at baseline

Lab values

• A prothrombin time test with an international normalised ratio (PT/INR) \>1.2
• PT-INR \>1.2. A clinical lab performed within a month of enrollment will be accepted to meet this exclusion criteria

Other

• Children unable to tolerate oral supplementation
• Use of blood thinners, including chronic aspirin, chronic NSAIDS, warfarin etc.
• 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)
• Plans to try additional complementary interventions or diets during the study period
• Subjects unable to tolerate oral supplementation
• Use of blood thinners, including chronic aspirin, chronic NSAIDS, warfarin etc. (Symptomatic use of NSAIDS for acute fever or pain permitted)

• 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
• 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.)
• Male and female, aged ≥2 years
• Ability to comprehend and use Standard American English