Modified Atkins Diet Plus KetoCal for Adult Epilepsy

Completed · Not applicable

Conditions studied: Epilepsy, Seizure, Medically Resistant Epilepsy, Medically Resistant Seizures

In brief

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.

Key facts

Study ID

NCT01834482

Run by

Johns Hopkins University

People needed

80

Starts

2013-03-01

Expected to finish

2017-09-01

Last updated by the study team

2018-08-31

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Johns Hopkins University — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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