Status:

COMPLETED

Modified Atkins Diet Plus KetoCal for Adult Epilepsy

Lead Sponsor:

Johns Hopkins University

Collaborating Sponsors:

Nutricia Liverpool

Conditions:

Epilepsy

Seizure

Eligibility:

All Genders

18-100 years

Phase:

NA

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...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

March 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2017

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT01834482

Start Date

March 1 2013

End Date

September 1 2017

Last Update

August 31 2018

Active Locations (1)

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1

Johns Hopkins University

Baltimore, Maryland, United States, 21287