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

NCT01880333 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2019-01-15

No results posted yet for this study

Summary

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.

Conditions

  • Refractory Epilepsy

Interventions

OTHER

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.

Sponsors & Collaborators

  • Lady Hardinge Medical College

    lead OTHER_GOV

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
9 Months
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01880333 on ClinicalTrials.gov