Infantile Spasms Clinical Trial
Official title:
Evaluation of the Modified Atkins Diet in Children With Infantile Spasms Refractory to Hormonal Therapy: a Randomized Controlled Trial
Infantile 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 however 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 to be effective for
intractable infantile spasms; often after ACTH and vigabatrin have failed.
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. Preliminary data have shown efficacy in
refractory infantile spasms. 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 infantile spasms refractory to
hormonal treatment in a randomized controlled trial.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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