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Trial record 18 of 1735 for:    Epilepsy

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

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ClinicalTrials.gov Identifier: NCT02369822
Recruitment Status : Unknown
Verified February 2015 by Shaymaa Maher Deifalla, Ain Shams University.
Recruitment status was:  Active, not recruiting
First Posted : February 24, 2015
Last Update Posted : February 24, 2015
Sponsor:
Information provided by (Responsible Party):
Shaymaa Maher Deifalla, Ain Shams University

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.

Condition or disease Intervention/treatment Phase
Idiopathic Epilepsy Dietary Supplement: Vitamin C Phase 2

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trial of Vitamin C as Add on Therapy for Children With Idiopathic Epilepsy
Study Start Date : February 2015
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : March 2016


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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Normal neuroimaging

Exclusion Criteria:

  • Developmental delay.
  • Suspected metabolic problems.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02369822


Locations
Egypt
Shaymaa Maher Deifalla
Cairo, Nasr City, Egypt
Sponsors and Collaborators
Ain Shams University
Investigators
Study Director: Iman A Elagouza, A Professor Faculty of Medicine, Ain Shams University

Responsible Party: Shaymaa Maher Deifalla, Lecturer of Pediatrics, Faculty of Medicine, Ain Shams University
ClinicalTrials.gov Identifier: NCT02369822     History of Changes
Other Study ID Numbers: Vitamin C, Children, Epilepsy
First Posted: February 24, 2015    Key Record Dates
Last Update Posted: February 24, 2015
Last Verified: February 2015

Keywords provided by Shaymaa Maher Deifalla, Ain Shams University:
Vitamin C
convulsions status
EEG
children

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vitamins
Ascorbic Acid
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents