NCT02369822

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 24, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

February 24, 2015

Status Verified

February 1, 2015

Enrollment Period

7 months

First QC Date

February 11, 2015

Last Update Submit

February 23, 2015

Conditions

Idiopathic Epilepsy

Keywords

Vitamin Cconvulsions statusEEGchildren

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • vitamin C level in children with epilepsy

    6 months

Study Arms (2)

Vitamin C supplemented

EXPERIMENTAL

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

Dietary Supplement: Vitamin C

None supplemented

NO INTERVENTION

followed up for 1 month

Interventions

Vitamin CDIETARY_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

Vitamin C supplemented

Eligibility Criteria

Age2 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Normal neuroimaging

You may not qualify if:

  • Developmental delay.
  • Suspected metabolic problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaymaa Maher Deifalla

Cairo, Nasr City, Egypt

Location

MeSH Terms

Interventions

Ascorbic Acid

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • Iman A Elagouza, A Professor

    Faculty of Medicine, Ain Shams University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Pediatrics, Faculty of Medicine

Study Record Dates

First Submitted

February 11, 2015

First Posted

February 24, 2015

Study Start

February 1, 2015

Primary Completion

September 1, 2015

Study Completion

March 1, 2016

Last Updated

February 24, 2015

Record last verified: 2015-02

Locations

EG(1)