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| Sponsors and Collaborators: |
Johns Hopkins University Vascular Birthmarks Foundation |
|---|---|
| Information provided by: | Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT00639730 |
Purpose
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 we 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 | Intervention | Phase |
|---|---|---|
|
Epilepsy Sturge Weber Syndrome |
Dietary Supplement: modified Atkins diet |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Use of the Atkins Diet for Children With Sturge Weber Syndrome |
| Estimated Enrollment: | 5 |
| Study Start Date: | May 2006 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
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
|
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.
Eligibility| Ages Eligible for Study: | 2 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Eric H Kossoff, MD | 410-614-6054 | ekossoff@jhmi.edu |
| United States, Maryland | |
| Johns Hopkins Hospital | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Eric H Kossoff, MD 410-614-6054 ekossoff@jhmi.edu | |
| Principal Investigator: Eric H Kossoff, MD | |
| Sub-Investigator: Anne M Comi, MD | |
| Sub-Investigator: Zahava Turner, RD | |
| Principal Investigator: | Eric H Kossoff, MD | Johns Hopkins School of Medicine |
More Information
| Responsible Party: | Johns Hopkins School of Medicine ( Eric Kossoff MD ) |
| Study ID Numbers: | NA_00003359 |
| Study First Received: | March 14, 2008 |
| Last Updated: | March 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00639730 |
| Health Authority: | Johns Hopkins School of Medicine United States: |
|
Epilepsy |
|
Angiomatosis Cerebral Infarction Brain Diseases Klippel-Trenaunay-Weber Syndrome Cerebrovascular Disorders Parkes Weber syndrome Weber syndrome Sturge-Weber Syndrome Hemangioma Abnormalities, Multiple Brain Ischemia Congenital Abnormalities Ectodermal Dysplasia Skin Diseases, Genetic Neurocutaneous Syndromes |
Skin Diseases Stroke Vascular Diseases Skin Abnormalities Central Nervous System Diseases Sturge-Weber syndrome Ischemia Brain Stem Infarctions Ectodermal dysplasia Genetic Diseases, Inborn Epilepsy Klippel Trenaunay Weber syndrome Brain Infarction Infarction Ectodermal dysplasias |
|
Neoplasms Pathologic Processes Disease Neoplasms by Histologic Type |
Syndrome Nervous System Diseases Neoplasms, Vascular Tissue Cardiovascular Diseases |
