Use of the Atkins Diet for Children With Sturge Weber Syndrome
Primary Purpose
Epilepsy, Sturge Weber Syndrome
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
modified Atkins diet
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy
Eligibility Criteria
Inclusion Criteria:
- 2-18 years
- Sturge Weber syndrome
- Monthly seizures (at least)
- Tried at least two anticonvulsants
Exclusion Criteria:
- Prior use of the Atkins or ketogenic diets
- Patients with non-epileptic seizures (pseudoseizures) will be excluded
- Patients that are pregnant or become pregnant during the study will be excluded
- High cholesterol
Sites / Locations
- Johns Hopkins Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
This is open-label - all patients are placed on the diet. There is no control or placebo arm.
Outcomes
Primary Outcome Measures
Seizures
Seizure frequency will be compared to baseline (pre-Diet).
Secondary Outcome Measures
Ketosis
Safety (stroke like events)
Full Information
NCT ID
NCT00639730
First Posted
March 14, 2008
Last Updated
May 26, 2010
Sponsor
Johns Hopkins University
Collaborators
Vascular Birthmarks Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00639730
Brief Title
Use of the Atkins Diet for Children With Sturge Weber Syndrome
Official Title
Use of the Atkins Diet for Children With Sturge Weber Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Johns Hopkins University
Collaborators
Vascular Birthmarks Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Sturge Weber Syndrome
Keywords
Epilepsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
This is open-label - all patients are placed on the diet. There is no control or placebo arm.
Intervention Type
Dietary Supplement
Intervention Name(s)
modified Atkins diet
Intervention Description
High fat, low carbohydrate diet
Primary Outcome Measure Information:
Title
Seizures
Description
Seizure frequency will be compared to baseline (pre-Diet).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Ketosis
Time Frame
6 months
Title
Safety (stroke like events)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
2-18 years
Sturge Weber syndrome
Monthly seizures (at least)
Tried at least two anticonvulsants
Exclusion Criteria:
Prior use of the Atkins or ketogenic diets
Patients with non-epileptic seizures (pseudoseizures) will be excluded
Patients that are pregnant or become pregnant during the study will be excluded
High cholesterol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric H Kossoff, MD
Organizational Affiliation
Johns Hopkins School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17324628
Citation
Kossoff EH, Turner Z, Bluml RM, Pyzik PL, Vining EP. A randomized, crossover comparison of daily carbohydrate limits using the modified Atkins diet. Epilepsy Behav. 2007 May;10(3):432-6. doi: 10.1016/j.yebeh.2007.01.012. Epub 2007 Feb 26.
Results Reference
background
PubMed Identifier
16499770
Citation
Kossoff EH, McGrogan JR, Bluml RM, Pillas DJ, Rubenstein JE, Vining EP. A modified Atkins diet is effective for the treatment of intractable pediatric epilepsy. Epilepsia. 2006 Feb;47(2):421-4. doi: 10.1111/j.1528-1167.2006.00438.x.
Results Reference
background
Learn more about this trial
Use of the Atkins Diet for Children With Sturge Weber Syndrome
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