Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00436631
Status:
COMPLETED
Last Update Posted:
2015-09-02
First Post:
2007-02-16
Brief Title:
Internet Administration of the Modified Atkins Diet for Adults With Intractable Epilepsy
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Internet Administration of the Modified Atkins Diet for Adults With Intractable Epilepsy
Status:
COMPLETED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective open-label no control or blind study to continue to determine whether the modified Atkins diet reduces seizures creates ketosis and is well tolerated in adults not children with epilepsy This study will enroll and manage patients via email phone and fax and without dietitian involvement primary difference from previous studies It is a 3 month study
Detailed Description:
Patients will have contacted either Dr Kossoff or Dr Cervenka either via referral or self-referral
Inclusion over 18 years of age at least weekly seizures or 4 per month tried at least 2 medications for your seizures have email and fax access are not very underweight or have high cholesterol have not had status epilepticus seizure lasting over 30 minutes in the past 6 months and have not tried the Atkins diet before or the ketogenic diet within the past year All patients will need to have a local primary care doctor or neurologist willing to be available in case of emergencies You and your local physician both need to speak and write in English and patients MUST be in the United States to participate The patient NOT a caregiver must be the person to email the investigators - a family member cannot be the contact person
If the patient agrees we will send and they will fax back within 2 weeks
1 Signed consent
2 Signed note from their neurologistprimary care provider attached
3 6 months of medical records to confirm their qualification
4 3-day food record can be emailed by the patient
5 Labs CBC CMP fasting lipid profile urine calcium urine creatinine urine hcG if female form attached
After that we will send information on how to do the diet via email they will maintain monthly calendars and after 3 months we will decide if the diet is helpful After that time point they can continue it on their own with periodic followup with either us or their local neurologist
Inclusion over 18 years of age at least weekly seizures or 4 per month tried at least 2 medications for your seizures have email and fax access are not very underweight or have high cholesterol have not had status epilepticus seizure lasting over 30 minutes in the past 6 months and have not tried the Atkins diet before or the ketogenic diet within the past year All patients will need to have a local primary care doctor or neurologist willing to be available in case of emergencies You and your local physician both need to speak and write in English and patients MUST be in the United States to participate The patient NOT a caregiver must be the person to email the investigators - a family member cannot be the contact person
If the patient agrees we will send and they will fax back within 2 weeks
1 Signed consent
2 Signed note from their neurologistprimary care provider attached
3 6 months of medical records to confirm their qualification
4 3-day food record can be emailed by the patient
5 Labs CBC CMP fasting lipid profile urine calcium urine creatinine urine hcG if female form attached
After that we will send information on how to do the diet via email they will maintain monthly calendars and after 3 months we will decide if the diet is helpful After that time point they can continue it on their own with periodic followup with either us or their local neurologist
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None