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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 26, 2014