Epileptic Spasms Clinical Trial
Official title:
Evaluation of the Modified Atkins Diet in Children With Epileptic Spasms Refractory to Hormonal Therapy: A Randomized Controlled Trial
Epileptic spasms are a difficult to treat epileptic condition in young children. The first line treatment is hormonal treatment, in the form of ACTH or oral steroids, which are effective in 60-70% of children. The condition does not respond well to other anti-epileptic drugs except vigabatrin which is not approved and hence has limited availability and high cost in India. The ketogenic diet, a high fat low carbohydrate diet has been found to be effective in refractory childhood epilepsy especially epileptic spasms. However, the ketogenic diet restricts calories and proteins and required strict weighing of foods. The modified Atkins diet (MAD) is a less restrictive diet which is easier for the parents to prepare and for the children to consume. In this study, it is planned to evaluate the efficacy of the MAD in children with epileptic spasms refractory to hormonal treatment in a randomized controlled trial.
Epileptic spasms comprise an infantile epileptic encephalopathy characterized by
hypsarrhythmia on EEG, and frequent neurodevelopmental regression. Unfortunately the
treatment of this disorder remains difficult. The first-line options which include hormonal
therapy, i.e., adrenocorticotropic hormone (ACTH) or oral corticosteroids, and vigabatrin are
effective in 60-70% of the patients. Hormonal therapy is considered the best available
treatment. Vigabatrin being expensive and of limited availability is not a feasible option
for most patients in our setting. Also, these are associated with significant side effects,
and high relapse rates. Newer drugs such as topiramate, zonisamide, and levetiracetam have
also been evaluated; however these drugs are less effective than ACTH. The ketogenic diet
(KD) is a high fat, low carbohydrate diet. It has been used for treatment of intractable
childhood epilepsy. The KD has also been shown in three retrospective studies to be effective
for intractable infantile spasms; often after ACTH and vigabatrin have failed. A few previous
studies have shown good efficacy of the ketogenic diet on infantile spasms. The traditional
ketogenic diet, with 4:1 ratio of fat: carbohydrate + protein has its drawbacks. It restricts
calories and fluids, and requires weighing of foods. Protein is generally restricted to 1
g/kg/day, with the majority of remaining calories in the form of fat. This may lead to
hypoproteinemia and growth problems. Hospitalization is generally advocated for diet
initiation, both for fasting and non-fasting initiation. Side effects of the diet include
kidney stones, constipation, acidosis, diminished growth, weight loss, and hyperlipidemia.
The modified Atkins diet is a non-pharmacologic therapy for intractable childhood epilepsy
that was designed to be a less restrictive alternative to the traditional ketogenic diet.
This diet is started on an outpatient basis without a fast, allows unlimited protein and fat,
and does not restrict calories or fluids. Early studies have demonstrated efficacy and
safety. Preliminary data have shown efficacy in refractory infantile spasms. Modified Atkins
diet may be of special importance in infants, as proteins are not restricted; hence fewer
problems with growth are expected. This diet is also ideal for resource-constraint settings
with paucity of trained dieticians. Hence this study has been planned to evaluate the
efficacy and tolerability of the modified Atkins diet in children with epileptic spasms
refractory to hormonal treatment in a randomized controlled trial.
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