A Phase 1 interventional study of modified Atkins diet in Epilepsy and Sturge Weber Syndrome, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2010-05-27.
Sponsored by Johns Hopkins University · Phase 1, Interventional, and Treatment
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.
If you agree to be in this study, we will ask you to do the following things:
Before the diet is started:
On the diet:
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:
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.
Exclusion Criteria:
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
Seizure frequency will be compared to baseline (pre-Diet).
Time frame: 6 months
Ketosis
Time frame: 6 months
Safety (stroke like events)
Time frame: 6 months
This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sturge-Weber Syndrome
Johns Hopkins University