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

This study has been completed.
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00181090
First received: September 10, 2005
Last updated: March 26, 2009
Last verified: March 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Epilepsy
 Behavioral: Modified Atkins diet
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy Seizures
U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Seizure control [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Ketosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Safety - cholesterol, kidney function, weight [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: February 2005
Study Completion Date: September 2006
  Eligibility

Ages Eligible for Study:   3 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00181090

Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Eric H Kossoff, MD Johns Hopkins University
  More Information

Additional Information:
Family and patient created website for study patients  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00181090     History of Changes
Other Study ID Numbers: 05-01-26-05
Study First Received: September 10, 2005
Last Updated: March 26, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Epilepsy
Ketosis
Atkins
seizures

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on June 18, 2013