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Efficacy of a Simplified Modified Atkins Diet in Children With Refractory Epilepsy

NCT01899898 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2019-01-15

No results posted yet for this study

Summary

One third of children with epilepsy have seizures that are medically intractable. Uncontrolled seizures pose a variety of risks to children, including higher rates of mortality, developmental delay and cognitive impairment. Epilepsy surgery is not a feasible option for most children with refractory epilepsy. The ketogenic diet and the modified Atkins diet have been shown to be effective alternative treatments in children with refractory epilepsy. However, these need parents to be educated, and understand complex instructions of weighing foods and diet preparation. Therefore, children with parents with low levels of literacy and poor socioeconomic status have not been able to benefit from these therapies. Also, the paucity of trained dieticians and limited availability of labeled foods in resource-constraint settings has made these dietary therapies even more inaccessible.

This study aimed to to develop a simple-to-administer variation of the modified Atkins diet for use in children with refractory epilepsy and to evaluate the efficacy and tolerability of this simplified modified Atkins diet in children with refractory epilepsy in a randomized controlled open-label trial.

Conditions

  • Refractory Epilepsy

Interventions

OTHER

Simplified Modified Atkins Diet

Modified Atkins diet with the following modifications: 1. Pictorial representation of various food items and exchange lists will be provided. 2. Instead of weights, we will provide standardized measures 3. We will calculate the amount of carbohydrates of daily readily available foods in the standardized measures 4. We will formulate recipes and diets based on locally available and culturally acceptable foods. 5. We will develop a parent instruction manual. 6. We will also develop methods for parents with low levels of literacy to maintain seizure logs. This will be done by using bars and color codes. 7. We will develop methods for parents with low levels of literacy to measure and record urine ketones. This will be done by using color codes.

DRUG

Antiepileptic drugs alone

The anti-epileptic drugs will be continued alone for 3 months following which they will be offered Simplified Modified Atkins Diet

Sponsors & Collaborators

  • Lady Hardinge Medical College

    lead OTHER_GOV

Principal Investigators

  • Satinder Aneja, MD · Pediatric Neurology, Department of Pediatrics, Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2015-11-30
Completion
2015-11-30

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 NCT01899898 on ClinicalTrials.gov