Use of the Atkins Diet for Children With Sturge Weber Syndrome
|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.|
|ClinicalTrials.gov Identifier: NCT00639730|
Recruitment Status : Completed
First Posted : March 20, 2008
Last Update Posted : May 27, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy Sturge Weber Syndrome||Dietary Supplement: modified Atkins diet||Phase 1|
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).
After being on the diet for one month, Dr. Kossoff will contact you by telephone to discuss how your child is doing. You can also speak with one of our dietitians. We will discuss the 3-day food record with you
You will be asked to come to the clinic (outpatient center, 5th floor) for two follow-up visits:
- after being on the diet for 3 months and
- after being on the diet for 6 months.
During these visits you will meet with one of our doctors and a dietitian. We will review your child's seizure control and health. We may obtain blood (about 2 teaspoons). We will check your child's urine for ketones and specific gravity.
If the diet is helping beyond 6 months, we will help your child continue on the diet with clinic visits and labs as necessary, at a carbohydrate amount that is most helpful.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of the Atkins Diet for Children With Sturge Weber Syndrome|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||May 2010|
This is open-label - all patients are placed on the diet. There is no control or placebo arm.
Dietary Supplement: modified Atkins diet
High fat, low carbohydrate diet
- Seizures [ Time Frame: 6 months ]Seizure frequency will be compared to baseline (pre-Diet).
- Ketosis [ Time Frame: 6 months ]
- Safety (stroke like events) [ Time Frame: 6 months ]
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): NCT00639730
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Eric H Kossoff, MD||Johns Hopkins School of Medicine|