Overview

This trial is active, not recruiting.

Condition idiopathic epilepsy
Treatment vitamin c
Phase phase 2
Sponsor Ain Shams University
Start date February 2015
End date September 2015
Trial size 60 participants
Trial identifier NCT02369822, Vitamin C, Children, Epilepsy

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
patients with refractory idiopathic epilepsy will receive vitamin C supplement according to age for 1 month
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
(No Intervention)
followed up for 1 month

Primary Outcomes

Measure
Seizure severity and frequency, EEG findings
time frame: up to 30 days

Secondary Outcomes

Measure
vitamin C level in children with epilepsy
time frame: 6 months

Eligibility Criteria

Male or female participants from 2 years up to 16 years old.

Inclusion Criteria: - Normal neuroimaging Exclusion Criteria: - Developmental delay. - Suspected metabolic problems.

Additional Information

Official title Trial of Vitamin C as Add on Therapy for Children With Idiopathic Epilepsy
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?
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Ain Shams University.