Clinical Trial: Use of the Atkins Diet for Children With Sturge Weber Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Use of the Atkins Diet for Children With Sturge Weber Syndrome

Brief Summary:

This research is being done to find out if the Atkins Diet can be used safely and effectively to reduce seizures in children who have Sturge Weber syndrome.

The ketogenic diet is a proven therapy for epilepsy, but can be difficult to use in children. The Atkins Diet is a high fat, high protein, low carbohydrate diet introduced in the 1970s to help with weight loss. It is different from the ketogenic diet in four major ways: no calorie restriction, no fluid restriction, no protein restriction, and is easy to start outside the hospital. People on the Atkins Diet become ketotic (produce high levels of ketones, a certain substance in the body), like patients on the ketogenic diet, and the investigators believe this may lead to seizure control.

Children aged 2-18 with Sturge Weber syndrome and seizures at least monthly, who have used at least two anti-seizure drugs may join. 5 children in total will be enrolled.


Detailed Summary:

If you agree to be in this study, we will ask you to do the following things:

Before the diet is started:

  • We will ask you to keep track of your child's seizures daily for 2 weeks before starting the Atkins diet and provide us with a 3-day food record as well.
  • Baseline blood (about 2 teaspoons) and urine work will be obtained.
  • We will give you a free copy of a carbohydrate-counting guide.
  • You will be asked to fill out a 3-day food record.

On the diet:

  • Give your child a daily calcium supplement and multivitamin.
  • Keep a daily seizure log.
  • Check urine for ketones (to make sure the diet is working) and specific gravity (to make sure your child is well hydrated) twice a week and when you come to clinic.
  • We will ask you to weigh your child at home every week, and we will weigh him or her when you come into clinic too.
  • Do not fluid restrict your child; please give plenty of carbohydrate-free fluids.
  • You will give 20 grams per day of carbohydrates. We will give you instructions on how to measure daily intake of carbohydrates.
  • We will not change medications for the first three months. Do not change your child's seizure medicines without checking with our doctors.
  • For the first three months, we ask you to avoid store-bought low-carbohydrate products (as they can have more carbohydrates than advertised).

Sponsor: Johns Hopkins University

Current Primary Outcome: Seizures [ Time Frame: 6 months ]

Seizure frequency will be compared to baseline (pre-Diet).


Original Primary Outcome: Seizure reduction [ Time Frame: 6 months ]

Current Secondary Outcome:

  • Ketosis [ Time Frame: 6 months ]
  • Safety (stroke like events) [ Time Frame: 6 months ]


Original Secondary Outcome: Same as current

Information By: Johns Hopkins University

Dates:
Date Received: March 14, 2008
Date Started: May 2006
Date Completion:
Last Updated: May 26, 2010
Last Verified: May 2010