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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.
Information provided by:
Johns Hopkins University Identifier:
First received: September 10, 2005
Last updated: March 26, 2009
Last verified: March 2009
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

Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00181090

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

Additional Information:
Publications: Identifier: NCT00181090     History of Changes
Other Study ID Numbers: 05-01-26-05
Study First Received: September 10, 2005
Last Updated: March 26, 2009

Keywords provided by Johns Hopkins University:

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases processed this record on August 18, 2017