A Phase 2/3 interventional study of Modified Atkins diet in Epileptic Spasms, sponsored by Lady Hardinge Medical College. Status unknown at 1 site in India. Open to participants aged 9 Months to 3 Years. Per ClinicalTrials.gov, last updated 2019-02-05.
Sponsored by Lady Hardinge Medical College · Phase 2/3, Interventional, and Treatment
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.
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's planned enrollment of 90 is above the median of 50 across 1,206 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →Lady Hardinge Medical College is the lead sponsor of 33 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Modified Atkins diet will be administered with carbohydrate restriction to 10 grams per day. Proteins will be allowed unrestricted and fats will be actively encouraged. The ongoing antiepileptic medication will be continued unchanged
Other: Modified Atkins diet
The control group will continue their anti-epileptic medication unchanged with no additional dietary input
This is a modified version of the ketogenic diet where-in carbohydrates are restricted without any protein or calorie restriction.
Proportion of children who achieved spasm freedom as per parental reports at 4 weeks, in both the groups
The proportion of children who achieve spasm freedom for at least 48 hours as per parental reports at the end of 4 weeks will be evaluated in the both the groups
Time frame: 4 weeks
Proportion of children who achieved >50% reduction of clinical spasm, as per parental reports at 4 weeks, in both the groups.
Proportion of children who achieved \>50% reduction of clinical spasm, as per parental reports at 4 weeks, in both the groups.
Time frame: 4 weeks
Proportion of children who achieve resolution of hypsarrhythmia on electro encephalogram at 4 weeks in both the groups.
Proportion of children who achieve resolution of hypsarrhythmia on electro encephalogram at 4 weeks in both the groups.
Time frame: 4 weeks
Description and proportion of the adverse effects of the diet as per parental reports in the diet group
Description and proportion of the adverse effects of the diet as per parental reports in the diet group
Time frame: 4 weeks
Plan to share: No
This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Lady Hardinge Medical College