Trial of Vitamin C as Add on Therapy for Children With Idiopathic Epilepsy

NCT ID: NCT02369822

Last Updated: 2015-02-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-03-31

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?

Conditions

Idiopathic Epilepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vitamin C supplemented

patients with refractory idiopathic epilepsy will receive vitamin C supplement according to age for 1 month

Group Type: EXPERIMENTAL

Vitamin C

Intervention Type: DIETARY_SUPPLEMENT

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

None supplemented

followed up for 1 month

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vitamin C

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Normal neuroimaging

Exclusion Criteria

• Developmental delay.
• Suspected metabolic problems.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Shaymaa Maher Deifalla

Lecturer of Pediatrics, Faculty of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Iman A Elagouza, A Professor

Role: STUDY_DIRECTOR

Faculty of Medicine, Ain Shams University

Locations

Shaymaa Maher Deifalla

Cairo, Nasr City, Egypt

Countries

Egypt

Other Identifiers

Vitamin C, Children, Epilepsy

Identifier Type: -

Identifier Source: org_study_id