Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
80 participants
INTERVENTIONAL
2013-03-31
2017-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Atkins Plus KetoCal for Childhood Epilepsy
NCT00681239
Dietary Therapy in Children With Refractory Epilepsy
NCT01983163
Use of the Atkins Diet for Adults With Intractable Epilepsy
NCT00121927
Use of the Atkins Diet for Children With Intractable Epilepsy: A Comparison of Daily Carbohydrate Limits
NCT00181090
Medium Chain Triglycerides as an Adjunct to the Modified Atkins Diet for Women With Catamenial Epilepsy
NCT02426047
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Modified Atkins diet plus KetoCal
Patients will receive the modified Atkins diet in combination with a KetoCal tetrapak daily for the first month. The second month, no tetrapaks will be given.
Modified Atkins diet
Patients will receive the modified Atkins diet with a 20 gram per day carbohydrate limit and encouragement to consume plenty of fat and eat to satiety.
KetoCal
Patients will receive a KetoCal 4:1 ratio (fat: carbohydrates and protein) liquid daily for the first month (if randomized to this arm of the study). They will also be started on the modified Atkins diet.
Modified Atkins diet
Patients will receive the modified Atkins diet for the first month. The second month, they will be given the choice to also use KetoCal in addition to the modified Atkins diet if they choose to do so.
Modified Atkins diet
Patients will receive the modified Atkins diet with a 20 gram per day carbohydrate limit and encouragement to consume plenty of fat and eat to satiety.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Modified Atkins diet
Patients will receive the modified Atkins diet with a 20 gram per day carbohydrate limit and encouragement to consume plenty of fat and eat to satiety.
KetoCal
Patients will receive a KetoCal 4:1 ratio (fat: carbohydrates and protein) liquid daily for the first month (if randomized to this arm of the study). They will also be started on the modified Atkins diet.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* At least weekly seizures (or 4 per month). All seizure types allowed.
* Tried at least two anticonvulsants.
Exclusion Criteria
* Significantly underweight (Body Mass Index \<18.5)
* Prior use of the modified Atkins diet for ≥ 2 days
* Prior use of KetoCal® at any time for any duration
* Use of the ketogenic diet within the past year
* Kidney disease
* History of hypercholesterolemia (total cholesterol \> 300 mg/dl) or hypertriglyceridemia (triglycerides \> 200 mg/dl)
* Metabolic or mitochondrial disorder
* Pregnancy or breastfeeding
* Lactose intolerance or milk allergy
* Aversion to liquids or inability to eat solid food
18 Years
100 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nutricia Liverpool
INDUSTRY
Johns Hopkins University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mackenzie C. Cervenka, M.D.
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Johns Hopkins University
Baltimore, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Kossoff EH, Dorward JL, Turner Z, Pyzik PL. Prospective study of the modified atkins diet in combination with a ketogenic liquid supplement during the initial month. J Child Neurol. 2011 Feb;26(2):147-51. doi: 10.1177/0883073810375718. Epub 2010 Sep 10.
Cervenka MC, Terao NN, Bosarge JL, Henry BJ, Klees AA, Morrison PF, Kossoff EH. E-mail management of the modified Atkins Diet for adults with epilepsy is feasible and effective. Epilepsia. 2012 Apr;53(4):728-32. doi: 10.1111/j.1528-1167.2012.03406.x. Epub 2012 Feb 14.
Kossoff EH, Rowley H, Sinha SR, Vining EP. A prospective study of the modified Atkins diet for intractable epilepsy in adults. Epilepsia. 2008 Feb;49(2):316-9. doi: 10.1111/j.1528-1167.2007.01256.x. Epub 2007 Oct 5.
Related Links
Access external resources that provide additional context or updates about the study.
Adult Epilepsy Diet Center at Hopkins website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NA_00068726
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.