EpilepsyNCT00121927
Use of the Atkins Diet for Adults With Intractable Epilepsy
A study testing Atkins diet (15 grams/day carbohydrates) in people with Epilepsy, run by Johns Hopkins University at 1 site in United States.
Trial summary
This is a prospective study to determine whether the Atkins diet reduces seizures, creates ketosis, and is well tolerated in adults with epilepsy. Approximately 30 patients will be enrolled, expecting 20 to complete the 6-month study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Atkins diet (15 grams/day carbohydrates)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Jun 2007
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18 and over
- Weekly seizures or 4 times per month
- Use of at least 2 anticonvulsant drugs
Who cannot join
- Prior use of the Atkins diet for > 1 week
- Prior use of the ketogenic diet within the past year
- Kidney, heart disease, renal disease
- Hypercholesterolemia
- Pseudoseizures
- Pregnancy
Show all 9Show fewer
- Body mass index (BMI) below 18.5
- Status epilepticus within the past 6 months
- 2 week seizure-free period within the past 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Hospital GCRC
Baltimore, Maryland, 21287
About this study
This is a prospective study to determine whether the Atkins diet reduces seizures, creates ketosis, and is well tolerated in adults with epilepsy. Approximately 30 patients will be enrolled, expecting 20 to complete the 6-month study. The investigators plan to establish the seizure baseline and type, initiate the Atkins diet, then monitor its administration in terms of seizure reduction, ketosis, and side effects for a 6-month period.
Read the detailed description
Patients are seen in the Johns Hopkins General Clinical Research Center (GCRC) and started on a modified Atkins diet (15g/day of carbohydrates). Medications remain unchanged and labs are drawn. Followup is at 1 month, 3 months, and 6 months into the study. After 1 month, carbohydrates and medications can be altered. Ketosis (urine) is measured by patients semiweekly, weight weekly, and seizures daily and recorded on a calendar.
This study is ongoing with approximately 20 patients of 30 enrolled as of February 2006.
- Conditions
- Epilepsy
- Being tested
- Atkins diet (15 grams/day carbohydrates)
- Keywords
- intractable, ketogenic, ketosis, Atkins
- Medical subject headings
- Epilepsy, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atkins diet (15 grams/day carbohydrates)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure reduction
Secondary outcomes (2)
Ketosis
tolerability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2005 (estimated)
- Study startJun 2004
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Investigators
- Eric H Kossoff, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00121927
- Sponsor's protocol ID
- 04-02-27-08
- Status last verified
- Feb 2007
- First submitted
- 15 Jul 2005
- Last updated
- 27 Jan 2010
- Results posted
- No
Publications
Kossoff EH, Krauss GL, McGrogan JR, Freeman JM. Efficacy of the Atkins diet as therapy for intractable epilepsy. Neurology. 2003 Dec 23;61(12):1789-91. doi: 10.1212/01.wnl.0000098889.35155.72.
PubMed 14694049
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Atkins Diet for Adults With Intractable Epilepsy
- ClinicalTrials.gov ID
- NCT00121927
- Acronym / sponsor ID
- 04-02-27-08
- Conditions
- Epilepsy
- Keywords
- intractable, ketogenic, ketosis, Atkins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- Jun 2004
- Study completion
- Jun 2007
- First posted
- 21 Jul 2005 (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 is a prospective study to determine whether the Atkins diet reduces seizures, creates ketosis, and is well tolerated in adults with epilepsy. Approximately 30 patients will be enrolled, expecting 20 to complete the 6-month study. The investigators plan to establish the seizure baseline and type, initiate the Atkins diet, then monitor its administration in terms of seizure reduction, ketosis, and side effects for a 6-month period.
Detailed description
Patients are seen in the Johns Hopkins General Clinical Research Center (GCRC) and started on a modified Atkins diet (15g/day of carbohydrates). Medications remain unchanged and labs are drawn. Followup is at 1 month, 3 months, and 6 months into the study. After 1 month, carbohydrates and medications can be altered. Ketosis (urine) is measured by patients semiweekly, weight weekly, and seizures daily and recorded on a calendar.
This study is ongoing with approximately 20 patients of 30 enrolled as of February 2006.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages 18 and over
- Weekly seizures or 4 times per month
- Use of at least 2 anticonvulsant drugs
Key exclusion criteria (9 listed)
- Prior use of the Atkins diet for > 1 week
- Prior use of the ketogenic diet within the past year
- Kidney, heart disease, renal disease
- Hypercholesterolemia
- Pseudoseizures
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 |
|---|---|---|
| Atkins diet (15 grams/day carbohydrates) | Behavioural | – |
Primary outcome
Seizure reduction
2 secondary outcomes
Ketosis
tolerability
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 Jan 2010.
- Background: PubMed 14694049Kossoff EH, Krauss GL, McGrogan JR, Freeman JM. Efficacy of the Atkins diet as therapy for intractable epilepsy. Neurology. 2003 Dec 23;61(12):1789-91. doi: 10.1212/01.wnl.0000098889.35155.72.
- Center websiteLink provided by the sponsor.
- Patient support network (non-medical) websiteLink provided by the sponsor.
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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 University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atkins diet (15 grams/day carbohydrates) in people with Epilepsy, 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 3 inclusion and 9 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 Jan 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.
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?
Seizure reduction. 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 NCT00121927, which also lists 1 linked publication.
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 Jan 2010.