Clinical trial NCT01834482: Modified Atkins Diet Plus KetoCal for Adult Epilepsy
Official title: A Randomized, Open-label Evaluation of KetoCal® in Initial Combination With the Modified Atkins Diet for the Dietary Management of Intractable Adult Epilepsy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Seizure
Medically Resistant Epilepsy
Medically Resistant Seizures
Keywords: seizures
epilepsy
adult
intractable
medically refractory
Atkins
ketogenic
diet
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Nutricia Liverpool
First posted: 2013-04-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The modified Atkins diet (MAD) has been shown to be effective in treating children and adults with medically resistant seizures. A recent study in children showed that the use of KetoCal® once per day in addition to the MAD appeared to be beneficial when used during the first month. The investigators hypothesize that including a daily KetoCal® liquid tetrapak with one meal during the initial month of the MAD will produce urinary ketosis in more adult patients than the MAD alone and will lead to greater seizure reduction.


Eligibility criteria: Inclusion Criteria:

* Adults ages \>17 years.
* At least weekly seizures (or 4 per month). All seizure types allowed.
* Tried at least two anticonvulsants.

Exclusion Criteria:

* Unwilling to restrict carbohydrates
* 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

Primary outcomes:
measure: Ketosis
timeFrame: 1 month
Secondary outcomes:
measure: Seizure reduction
timeFrame: 2 months
measure: Tolerability and taste
timeFrame: 2 months
measure: Side effects
timeFrame: 2 months
measure: Study completion rate
timeFrame: 2 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Mackenzie C. Cervenka, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.