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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:
ClinicalTrials.gov Identifier:
NCT00181090
First Posted: September 16, 2005
Last Update Posted: March 27, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Johns Hopkins University
  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
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Seizure control [ Time Frame: 6 months ]
  • Ketosis [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Tolerability [ Time Frame: 6 months ]
  • Safety - cholesterol, kidney function, weight [ Time Frame: 6 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications:
ClinicalTrials.gov Identifier: NCT00181090     History of Changes
Other Study ID Numbers: 05-01-26-05
First Submitted: September 10, 2005
First Posted: September 16, 2005
Last Update Posted: March 27, 2009
Last Verified: March 2009

Keywords provided by Johns Hopkins University:
Epilepsy
Ketosis
Atkins
seizures

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