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Clinical Trials/NCT00181090
NCT00181090
Completed
Phase 1

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

Johns Hopkins University1 site in 1 country30 target enrollmentFebruary 2005
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ConditionsEpilepsy

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Epilepsy
Sponsor
Johns Hopkins University
Enrollment
30
Locations
1
Primary Endpoint
Seizure control
Status
Completed
Last Updated
17 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2005
End Date
September 2006
Last Updated
17 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Seizure control

Time Frame: 6 months

Ketosis

Time Frame: 6 months

Secondary Outcomes

  • Tolerability(6 months)
  • Safety - cholesterol, kidney function, weight(6 months)

Study Sites (1)

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