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

Idiopathic Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02369822
• Other study ID #: Vitamin C, Children, Epilepsy
• Status: Active, not recruiting
• Phase: Phase 2
• First received: February 11, 2015
• Last updated: February 23, 2015
• Start date: February 2015
• Est. completion date: March 2016

Study information

• Verified date: February 2015
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: March 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 16 Years

Eligibility

Inclusion Criteria:

• Normal neuroimaging

Exclusion Criteria:

• Developmental delay.

• Suspected metabolic problems.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy
• Idiopathic Epilepsy

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
Egypt	Shaymaa Maher Deifalla	Cairo	Nasr City

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 30 days	No
Secondary	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	6 months	No