Trial of Vitamin C as Add on Therapy for Children With Idiopathic Epilepsy
Primary Purpose
Idiopathic Epilepsy
Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Vitamin C
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Epilepsy focused on measuring Vitamin C, convulsions status, EEG, children
Eligibility Criteria
Inclusion Criteria:
- Normal neuroimaging
Exclusion Criteria:
- Developmental delay.
- Suspected metabolic problems.
Sites / Locations
- Shaymaa Maher Deifalla
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Vitamin C supplemented
None supplemented
Arm Description
patients with refractory idiopathic epilepsy will receive vitamin C supplement according to age for 1 month
followed up for 1 month
Outcomes
Primary Outcome Measures
Seizure severity and frequency, EEG findings
Seizure severity based on the Chalfont seizre severity scale and daily seizure frequency will be measured before and 30 days after vitamin C supplementation in children with intractable idiopathic epilepsy
Secondary Outcome Measures
vitamin C level in children with epilepsy
children with epilepsy will be recruited over a period of 6 months and we will measure vitamin C level in their blood
Full Information
NCT ID
NCT02369822
First Posted
February 11, 2015
Last Updated
February 23, 2015
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT02369822
Brief Title
Trial of Vitamin C as Add on Therapy for Children With Idiopathic Epilepsy
Official Title
Trial of Vitamin C as Add on Therapy for Children With Idiopathic Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
March 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
There are no solid treatment guidelines for idiopathic intractable epilepsy in children. The investigators propose that vitamin C being an antioxidant will improve seizure frequency and EEG in children with idiopathic intractable epilepsy.
Detailed Description
Is vitamin C; being an antioxidant based on the hypothesis of oxidative stress as a provocation factor for idiopathic epilepsy low in those with idiopathic epilepsy, and is it lower in those with refractory than those with newly diagnosed? Will vitamin C supplementation for 1 month be efficient to raise the vitamin C level and will it improve seizures and EEG findings in those with idiopathic epilepsy?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Epilepsy
Keywords
Vitamin C, convulsions status, EEG, children
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vitamin C supplemented
Arm Type
Experimental
Arm Description
patients with refractory idiopathic epilepsy will receive vitamin C supplement according to age for 1 month
Arm Title
None supplemented
Arm Type
No Intervention
Arm Description
followed up for 1 month
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin C
Intervention Description
those who are 2-3 years will receive 400 mg/day, 4-8 years will receive 500 mg/day, those who are 9-13 years will receive 1000 mg/day, and from 14-16 years will receive 1500 mg/day
Primary Outcome Measure Information:
Title
Seizure severity and frequency, EEG findings
Description
Seizure severity based on the Chalfont seizre severity scale and daily seizure frequency will be measured before and 30 days after vitamin C supplementation in children with intractable idiopathic epilepsy
Time Frame
up to 30 days
Secondary Outcome Measure Information:
Title
vitamin C level in children with epilepsy
Description
children with epilepsy will be recruited over a period of 6 months and we will measure vitamin C level in their blood
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Normal neuroimaging
Exclusion Criteria:
Developmental delay.
Suspected metabolic problems.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iman A Elagouza, A Professor
Organizational Affiliation
Faculty of Medicine, Ain Shams University
Official's Role
Study Director
Facility Information:
Facility Name
Shaymaa Maher Deifalla
City
Cairo
State/Province
Nasr City
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Trial of Vitamin C as Add on Therapy for Children With Idiopathic Epilepsy
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