Prospective Study of Comparison Between the Modified Atkins Diet and Classic Ketogenic Diet for Intractable Childhood Epilepsy

Completed

• Conditions: Epilepsy

• Registration Number: NCT02100501
• Lead Sponsor: Yonsei University

Brief Summary

The Ketogenic diet is a now proven, evidence based treatment of refractory epilepsy. the classic ketogenic diet (KD) is based on a ratio of fat to carbohydrate and protein, usually 3:1 or 4:1. Fat is proven long-chain triglycerides. The efficacy of the KD has been proven by many multicenter trials. But, side effects of ketogenic diet therapy is severe. The modified atkins diet (MAD) was designed and investigated at Johns Hopkins Hospital, which aimed to propose a less restrictive dietary treatment that would be more palatable to children and adolescents with less side effects. The MAD consist of a nearly balance diet (60% fat, 30% protein, and 10% carbohydrates by weight), without any restriction on the recommended daily calories. Some literature suggested that the MAD is an effective treatment for refractory epilepsy. But, no randomised controlled study has been tried. the investigators aimed in this prospective study to evaluate the efficacy, safety and tolerability of MAD comparing to KD. The patients were recruited between age 3 to 18 years old with intractable epilepsy. Enrolled patients were randomly assigned to either one of two groups; the KD group and MAD group. The patients were required to attend outpatient clinic after 1, 3month to record their seizure frequency and severity, while their dietary treatment.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Study First Submitted: 2014-03-26
• Study First Submitted QC: 2014-03-31
• Study First Posted: 2014-04-01
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-24
• Last Update Posted: 2015-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

• Age ranged from 1 to 18 year old patients diagnosed with intractable epilepsy which shows frequency with more than 1 per week, 4 per month even though at least more than 2 antiepileptic drug treatment.

Exclusion Criteria

• Patients heve been tried KD or MAD before.
• Patients with renal stones, hyperlipidemia, cardiologic problems.
• Other conditions not adjust for dietary therapy.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
seizure outcome 3months after dietary therapy.	3 months	1 and 3 month after dietary therapy, enrolled patients were required to visit outpatient clinic to record their seizure frequency. we compile statistics and compare seizure frequencies before and after dietary treatment in each KD group and MAD group.

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Seodaemun-gu, Korea, Republic of