Evaluation of the Modified Atkins Diet in Children With Epileptic Spasms

February 1, 2019 updated by: Suvasini Sharma, Lady Hardinge Medical College

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Delhi
      • New Delhi, Delhi, India, 110018
        • Recruiting
        • Lady Hardinge Medical College
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 9 months to 3 years
  • Presence of epileptic spasms in clusters in child 9 months to <3years of age, with electroencephalographic evidence of hypsarrhythmia or its variants, persisting, at least one cluster per day, despite treatment with either oral corticosteroids or adrenocorticotrophic hormone (ACTH) and one additional anticonvulsant (valproate/ benzodiazepine/ vigabatrin/ topiramate/ zonisamide/ levetiracetam) for at least 4 weeks.

Exclusion Criteria:

  • Children with known or suspected inborn error of metabolism
  • Children with renal, pulmonary, cardiac or hepatic dysfunction
  • Severe malnutrition (weight for length or weight for height less than -3 Z score as per WHO growth charts)
  • Motivational or psychosocial issues in the family which might affect the compliance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diet arm

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

This is a modified version of the ketogenic diet where-in carbohydrates are restricted without any protein or calorie restriction.
No Intervention: Control
The control group will continue their anti-epileptic medication unchanged with no additional dietary input

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of children who achieved spasm freedom as per parental reports at 4 weeks, in both the groups
Time Frame: 4 weeks
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
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 achieved >50% reduction of clinical spasm, as per parental reports at 4 weeks, in both the groups.
4 weeks
Proportion of children who achieve resolution of hypsarrhythmia on electro encephalogram 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.
4 weeks
Description and proportion of the adverse effects of the diet as per parental reports in the diet group
Time Frame: 4 weeks
Description and proportion of the adverse effects of the diet as per parental reports in the diet group
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2019

Primary Completion (Anticipated)

January 14, 2022

Study Completion (Anticipated)

March 31, 2022

Study Registration Dates

First Submitted

January 4, 2019

First Submitted That Met QC Criteria

January 12, 2019

First Posted (Actual)

January 16, 2019

Study Record Updates

Last Update Posted (Actual)

February 5, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Epileptic Spasms

Clinical Trials on Modified Atkins diet

3
Subscribe