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Modified Atkins Diet Plus KetoCal for Adult Epilepsy
This study is ongoing, but not recruiting participants.
Sponsor:
Johns Hopkins University
Collaborator:
Nutricia Liverpool
Information provided by (Responsible Party):
Mackenzie Cervenka, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01834482
First received: April 1, 2013
Last updated: March 12, 2017
Last verified: March 2017
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Purpose
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.
| Condition | Intervention |
|---|---|
| Epilepsy Seizure Medically Resistant Epilepsy Medically Resistant Seizures | Dietary Supplement: Modified Atkins diet Dietary Supplement: KetoCal |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Genetics Home Reference related topics:
pyridoxal 5'-phosphate-dependent epilepsy
U.S. FDA Resources
Further study details as provided by Mackenzie Cervenka, Johns Hopkins University:
Primary Outcome Measures:
- Ketosis [ Time Frame: 1 month ]Time to urinary ketosis in days will be recorded and whether or not patients achieve serum ketosis at 1 month and 2 months.
Secondary Outcome Measures:
- Seizure reduction [ Time Frame: 2 months ]The percent seizure reduction compared to baseline (1 month before beginning the diet) will be recorded at 1 month and 2 months.
- Tolerability and taste [ Time Frame: 2 months ]Patients will be asked to rank convenience, taste, texture, and tolerability of the liquid on a 10 point scale (1 = poor, 10 = excellent).
- Side effects [ Time Frame: 2 months ]Patients will be screened for constipation and asked if they have experienced any side effects related to use of the modified Atkins diet and KetoCal® at 1 and 2 months.
- Study completion rate [ Time Frame: 2 months ]
| Estimated Enrollment: | 80 |
| Study Start Date: | March 2013 |
| Estimated Study Completion Date: | September 2017 |
| Estimated Primary Completion Date: | September 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 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.
|
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.
Other Names:
|
|
Active Comparator: 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.
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 100 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01834482
Please refer to this study by its ClinicalTrials.gov identifier: NCT01834482
Locations
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21287 | |
Sponsors and Collaborators
Johns Hopkins University
Nutricia Liverpool
Investigators
| Principal Investigator: | Mackenzie C. Cervenka, M.D. | Johns Hopkins University |
More Information
Additional Information:
Publications:
| Responsible Party: | Mackenzie Cervenka, Assistant Professor of Neurology, Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT01834482 History of Changes |
| Other Study ID Numbers: |
NA_00068726 |
| Study First Received: | April 1, 2013 |
| Last Updated: | March 12, 2017 |
Keywords provided by Mackenzie Cervenka, Johns Hopkins University:
|
seizures epilepsy adult intractable |
medically refractory Atkins ketogenic diet |
Additional relevant MeSH terms:
|
Epilepsy Seizures Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on August 17, 2017