NCT01834482

Modified Atkins Diet Plus KetoCal for Adult Epilepsy

A Randomized, Open-label Evaluation of KetoCal® in Initial Combination With the Modified Atkins Diet for the Dietary Management of Intractable Adult Epilepsy.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epilepsy
• Seizure
• Medically Resistant Epilepsy
• Medically Resistant Seizures

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.
DIETARY_SUPPLEMENT	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.

Timeline

• Start date: 2013-03-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2013-04-18
• Last updated: 2018-08-31

Locations

1 site across 1 country: United States