EpilepsyPhase 1NCT00639730
Use of the Atkins Diet for Children With Sturge Weber Syndrome
A Phase 1 study testing modified Atkins diet in people with Epilepsy and Sturge Weber Syndrome, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Epilepsy, Sturge Weber Syndrome
- What is being tested?
- modified Atkins diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to May 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 2-18 years
- Sturge Weber syndrome
- Monthly seizures (at least)
- Tried at least two anticonvulsants
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Epilepsy, Sturge Weber Syndrome
- Being tested
- modified Atkins diet
- Keywords
- Epilepsy
- Medical subject headings
- Epilepsy, Sturge-Weber Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified Atkins dietDietary supplement
High fat, low carbohydrate diet
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | This is open-label - all patients are placed on the diet. There is no control or placebo arm. Receives: Dietary Supplement: modified Atkins diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizures
Seizure frequency will be compared to baseline (pre-Diet).
Measured: 6 months
Secondary outcomes (2)
Ketosis
Measured: 6 months
Safety (stroke like events)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2008 (estimated)
- Study startMay 2006
- Primary completionMar 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Vascular Birthmarks Foundation
- Investigators
- Eric H Kossoff, MD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639730
- Sponsor's protocol ID
- NA_00003359
- Status last verified
- May 2010
- First submitted
- 14 Mar 2008
- Last updated
- 27 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 17324628Kossoff 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.
PubMed 16499770
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Atkins Diet for Children With Sturge Weber Syndrome
- ClinicalTrials.gov ID
- NCT00639730
- Acronym / sponsor ID
- NA_00003359
- Conditions
- Epilepsy, Sturge Weber Syndrome
- Keywords
- Epilepsy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Vascular Birthmarks Foundation
- Study start
- May 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 20 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Dietary Supplement: modified Atkins dietThis is open-label - all patients are placed on the diet. There is no control or placebo arm. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 2-18 years
- Sturge Weber syndrome
- Monthly seizures (at least)
- Tried at least two anticonvulsants
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| modified Atkins dietHigh fat, low carbohydrate diet | Dietary supplement | A |
Primary outcome
Seizures
Time frame: 6 months
Seizure frequency will be compared to baseline (pre-Diet).
2 secondary outcomes
Ketosis
Time frame: 6 months
Safety (stroke like events)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2010.
- Background: PubMed 17324628Kossoff 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.
- Background: PubMed 16499770Kossoff 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.
Related trials for Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric H Kossoff, MD principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing modified Atkins diet in people with Epilepsy and Sturge Weber Syndrome, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizures (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00639730, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2010.