Omega-DEK + L-carnitine for Speech Apraxia

This trial aims to explore how Omega-DEK, a nutritional supplement combined with L-carnitine, can help children with childhood apraxia of speech (CAS). Over 20 weeks, researchers will assess whether this combination improves speech in children diagnosed with CAS. Initially, all participants receive the treatment for 12 weeks. Then, they are randomly assigned to either continue the treatment or receive a placebo (a non-active substitute) for 8 weeks. Ideal participants are children aged 3 to 6 with a confirmed diagnosis of CAS who can understand and use English. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of children.

The trial requires that any new chronic medications must have been stable for more than 3 months before joining. If you're on a new medication or plan to start one during the study, you might not be eligible. It's best to discuss your specific situation with the trial team.

Research shows that L-carnitine, one of the treatments in this study, is usually well-tolerated. Previous studies found that L-carnitine can be safely used in children, with few reports of side effects. Although specific safety information for Omega-DEK is not yet available, the known safety of L-carnitine suggests that the combination might also be well-tolerated.

Most treatments for childhood apraxia of speech focus on intensive speech therapy aimed at improving motor planning and coordination. However, Omega-DEK combined with L-carnitine is unique because it introduces a nutritional approach to managing the condition. Omega-DEK incorporates omega-3 fatty acids, known for their role in brain health, which may enhance neural connectivity and speech processing. L-carnitine supports energy production in brain cells, potentially boosting cognitive function. Researchers are excited about these treatments because they offer a novel way to address speech apraxia by directly supporting brain function, rather than just relying on traditional therapy techniques.

Research has shown that supplements like Omega-3 and Omega-6 can improve language skills in children with speech difficulties. One study found that children who took these supplements improved their language abilities over three months. L-carnitine, often part of a balanced diet, is under investigation for its potential to support brain health and possibly aid speech. In this trial, participants will receive Omega-DEK and L-carnitine for 12 weeks. Although direct evidence on using Omega-DEK with L-carnitine specifically for childhood apraxia of speech (CAS) is limited, these ingredients are believed to support brain function and language development. This combination targets brain areas involved in speech, suggesting it could benefit children with CAS. After the initial 12 weeks, participants will be randomized to continue with Omega-DEK or switch to a placebo for an additional 8 weeks.¹²⁶⁷⁸