Evaluation of the Modified Atkins Diet in Young Children With Refractory Epilepsy

January 12, 2019 updated by: Satinder Aneja, Lady Hardinge Medical College

Phase 2/3 Study of the Modified Atkins Diet in Young Children With Refractory Epilepsy

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. Modified Atkins diet is of special importance in resource constraint settings with paucity of trained dieticians. However, there is paucity published data on the use of the modified Atkins diet in refractory epilepsy in young children. This study aims to evaluate the efficacy and tolerability of the modified Atkins diet in refractory epilepsy in young children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

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 Locations

    • Delhi
      • New Delhi, Delhi, India, 110001
        • Department of Pediatrics, Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital

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

9 months to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age: 9 months to 3 years.
  2. Seizures persisting at least three per week for > 1 month despite the appropriate use of at least 2 Anti-epileptic drugs.

Exclusion Criteria:

  1. Known or suspected inborn error of metabolism, as evidenced by: Clinical suspicion of metabolic disorder as evidenced by 2 or more of the following- a history of parental consanguinity, prior affected siblings, unexplained vomiting, intermittent worsening of symptoms, recurrent episodes of lethargy, altered sensorium, or ataxia, hepatosplenomegaly on examination And/ or 2 or more of the following biochemical abnormalities High blood ammonia (>80mmol/L), High arterial lactate (>2 mmol/L), metabolic acidosis (pH <7.2), hypoglycaemia (blood sugar <40 mg/dl), abnormal urinary aminoacidogram, presence of reducing sugars or ketones in urine, and positive results on urine neurometabolic screening tests.
  2. Motivational or psychosocial issues in the family which would preclude compliance
  3. Systemic illness- chronic hepatic, cardiac, renal or pulmonary disease
  4. Severe acute malnutrition.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Children on Modified Atkin Diet
Eligible children will be started on Modified Atkins diet with help of trained dietician. Carbohydrates intake will be restricted to 5 grams/ day in children<18 mo and 10grams/day in children 18mo- 3 years.Carbohydrate values of various food items will be explained in detail. Fats (e.g. cream, butter, oils, and ghee) will be encouraged. Proteins (cheese, fish, eggs, chicken, and soya products) will be unrestricted. Calcium and multivitamin supplementation will be done. Syrups will be restricted. Clear carbohydrates free fluids- will not be restricted. Medications will be changed to carbohydrate free preparations, wherever available. Diary of events will be recorded including seizure frequency and any adverse or positive effect. Urine ketones chart will be maintained.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of children with > 50% seizure reduction at 3 months
Time Frame: After 3 months of diet initiation
After 3 months of diet initiation

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency of adverse effects of the modified Atkins diet.
Time Frame: 3 months
3 months

Other Outcome Measures

Outcome Measure
Time Frame
Proportion of children with seizure freedom at 3 months
Time Frame: 3 months
3 months
Percentage of children discontinuing diet before 3 months as per parenteral reports
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Satinder Aneja, MD, Kalawati Saran Children's Hospital, Lady Hardinge Medical College, New Delhi, India

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

November 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

June 13, 2013

First Submitted That Met QC Criteria

June 14, 2013

First Posted (Estimate)

June 18, 2013

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 12, 2019

Last Verified

January 1, 2019

More Information

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.

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