Use of the Atkins Diet for Children With Intractable Epilepsy: A Comparison of Daily Carbohydrate Limits

Phase 1

Completed

• Conditions: Epilepsy

• Registration Number: NCT00181090
• Lead Sponsor: Johns Hopkins University

Brief Summary

This study is designed to further investigate the use of a modified Atkins diet for children with intractable, daily seizures. It is a follow-up to a study recently completed by our institution. In this 6-month study, children will be randomized to either 10 or 20 grams of carbohydrate per day, then crossed over to the opposite amount at 3 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-09-10
• Study First Submitted QC: 2005-09-10
• Study First Posted: 2005-09-16
• Study Completion: 2006-09
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-26
• Last Update Posted: 2009-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Ages 3-18
• Daily seizures or 7 per week
• Failed at least 2 anticonvulsants

Exclusion Criteria

• Prior use of the Atkins diet for over 1 week
• Significant heart, liver, or kidney disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Seizure control	6 months
Ketosis	6 months

Secondary Outcome Measures

Name	Time	Method
Tolerability	6 months
Safety - cholesterol, kidney function, weight	6 months

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States