Refractory Epilepsy Clinical Trial
Official title:
Phase 2/3 Study of a Simplified Modified Atkins Diet in Children With Refractory Epilepsy
One third of children with epilepsy have seizures that are medically intractable.
Uncontrolled seizures pose a variety of risks to children, including higher rates of
mortality, developmental delay and cognitive impairment. Epilepsy surgery is not a feasible
option for most children with refractory epilepsy. The ketogenic diet and the modified Atkins
diet have been shown to be effective alternative treatments in children with refractory
epilepsy. However, these need parents to be educated, and understand complex instructions of
weighing foods and diet preparation. Therefore, children with parents with low levels of
literacy and poor socioeconomic status have not been able to benefit from these therapies.
Also, the paucity of trained dieticians and limited availability of labeled foods in
resource-constraint settings has made these dietary therapies even more inaccessible.
This study aimed to to develop a simple-to-administer variation of the modified Atkins diet
for use in children with refractory epilepsy and to evaluate the efficacy and tolerability of
this simplified modified Atkins diet in children with refractory epilepsy in a randomized
controlled open-label trial.
n/a
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