- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00639730
Use of the Atkins Diet for Children With Sturge Weber Syndrome
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: A
This is open-label - all patients are placed on the diet.
There is no control or placebo arm.
|
High fat, low carbohydrate diet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Seizures
Time Frame: 6 months
|
Seizure frequency will be compared to baseline (pre-Diet).
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Ketosis
Time Frame: 6 months
|
6 months
|
Safety (stroke like events)
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Eric H Kossoff, MD, Johns Hopkins School of Medicine
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Disease
- Brain Ischemia
- Infarction
- Stroke
- Brain Infarction
- Hemangioma
- Neoplasms, Vascular Tissue
- Neurocutaneous Syndromes
- Angiomatosis
- Epilepsy
- Syndrome
- Klippel-Trenaunay-Weber Syndrome
- Sturge-Weber Syndrome
- Brain Stem Infarctions
Other Study ID Numbers
- NA_00003359
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Epilepsy
-
NaviFUS CorporationTaipei Veterans General Hospital, TaiwanCompletedDrug Resistant Epilepsy | Epilepsy, Drug Resistant | Intractable Epilepsy | Refractory Epilepsy | Drug Refractory Epilepsy | Epilepsy, Drug Refractory | Epilepsy, Intractable | Medication Resistant EpilepsyTaiwan
-
Great Ormond Street Hospital for Children NHS Foundation...Active, not recruitingEpilepsies, Partial | Intractable Epilepsy | Focal Epilepsy | Refractory Epilepsy | Epilepsy Intractable | Epilepsy in Children | Epilepsy, FocalUnited Kingdom
-
University of British ColumbiaTerminatedJuvenile Myoclonic Epilepsy | Childhood Absence Epilepsy | Juvenile Absence EpilepsyCanada
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruiting
-
Neuroelectrics CorporationRecruitingEpilepsy | Seizures | Refractory Epilepsy | Epilepsy, Tonic-Clonic | Epilepsy in Children | Seizures, Focal | Focal SeizureSpain, United States, France, Belgium
-
Oslo University HospitalCompletedEpilepsy | Generalized Epilepsy | Focal EpilepsyNorway
-
UCB Pharma SACompletedEpilepsy, Tonic-clonicPoland, Sweden, Hungary, Czechia
-
UCB PharmaCompletedEpilepsy, Tonic-clonic
-
University Hospital, LilleUnknownFocal Epilepsy | Epilepsy IntractableFrance
-
Xuanwu Hospital, BeijingPeking University; Beijing Tiantan Hospital; Qilu Hospital of Shandong University and other collaboratorsNot yet recruitingEpilepsy, Drug ResistantChina
Clinical Trials on modified Atkins diet
-
University of Wisconsin, MadisonNational Institutes of Health (NIH); Wisconsin Institute for Clinical and Translational...SuspendedEpilepsy | SeizuresUnited States
-
Johns Hopkins UniversityCompleted
-
Johns Hopkins UniversityTerminated
-
Johns Hopkins UniversityCompleted
-
Hugo W. Moser Research Institute at Kennedy Krieger...Active, not recruiting
-
University of VirginiaCompletedRelapsing Remitting Multiple SclerosisUnited States
-
Hadassah Medical OrganizationCompletedObese Type 2 Diabetic Patients
-
Loma Linda UniversityEnrolling by invitationTraumatic Brain InjuryUnited States
-
Oslo University HospitalCompleted
-
Johns Hopkins UniversityEnrolling by invitationEpilepsy | Coronary Disease | Cardiovascular Disease | Hypercholesterolemia | Heart Disease | Cerebrovascular Disease | Seizure | Carotid Intimal Medial Thickness 1United States