Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121927
Status:
COMPLETED
Last Update Posted:
2010-01-27
First Post:
2005-07-15
Brief Title:
Use of the Atkins Diet for Adults With Intractable Epilepsy
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Use of the Atkins Diet for Adults With Intractable Epilepsy
Status:
COMPLETED
Status Verified Date:
2007-02
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 study to determine whether the Atkins diet reduces seizures creates ketosis and is well tolerated in adults with epilepsy Approximately 30 patients will be enrolled expecting 20 to complete the 6-month study The investigators plan to establish the seizure baseline and type initiate the Atkins diet then monitor its administration in terms of seizure reduction ketosis and side effects for a 6-month period
Detailed Description:
Patients are seen in the Johns Hopkins General Clinical Research Center GCRC and started on a modified Atkins diet 15gday of carbohydrates Medications remain unchanged and labs are drawn Followup is at 1 month 3 months and 6 months into the study After 1 month carbohydrates and medications can be altered Ketosis urine is measured by patients semiweekly weight weekly and seizures daily and recorded on a calendar
This study is ongoing with approximately 20 patients of 30 enrolled as of February 2006
This study is ongoing with approximately 20 patients of 30 enrolled as of February 2006
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