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

February 23, 2015 updated by: Shaymaa Maher Deifalla, Ain Shams University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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?

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Nasr City
      • Cairo, Nasr City, Egypt
        • Shaymaa Maher Deifalla

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Normal neuroimaging

Exclusion Criteria:

  • Developmental delay.
  • Suspected metabolic problems.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin C supplemented
patients with refractory idiopathic epilepsy will receive vitamin C supplement according to age for 1 month
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
No Intervention: None supplemented
followed up for 1 month

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seizure severity and frequency, EEG findings
Time Frame: up to 30 days
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
vitamin C level in children with epilepsy
Time Frame: 6 months
children with epilepsy will be recruited over a period of 6 months and we will measure vitamin C level in their blood
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Director: Iman A Elagouza, A Professor, Faculty of Medicine, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

February 11, 2015

First Submitted That Met QC Criteria

February 23, 2015

First Posted (Estimate)

February 24, 2015

Study Record Updates

Last Update Posted (Estimate)

February 24, 2015

Last Update Submitted That Met QC Criteria

February 23, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vitamin C, Children, Epilepsy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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