Effect of Magnesium Supplementation for Children With Drug Resistant Idiopathic Epilepsy

Not Applicable

Completed

• Conditions: Drug Resistant Epilepsy
• Interventions: Dietary Supplement: Magnesium; Drug: Placebo - Concentrate

• Registration Number: NCT02982824
• Lead Sponsor: Ain Shams University

Brief Summary

Effect of oral magnesium sulfate (Mg) supplementation will be studied. Children with drug resistant idiopathic epilepsy following up in Pediatric Neurology Clinic, Ain Shams University, will be randomized to either Mg add-on treatment group or anti-epileptic drugs AEDs alone. Serum magnesium, seizure control and Intelligent quotation (IQ) will be done at base line and after 6 months of treatment.

Detailed Description

The Aim of this work was to study the effect of Magnesium as add on therapy on clinical seizure control in drug resistant idiopathic epilepsy and IQ.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-11-22
• Status Verified: 2016-12
• Study First Submitted QC: 2016-12-01
• Study First Posted: 2016-12-06
• Primary Completion: 2017-02
• Study Completion: 2017-03
• Last Update Submitted: 2017-05-07
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Children with drug resistant idiopathic epilepsy

Exclusion Criteria

• Structural, Metabolic, Infectious and Unknown etiology epilepsy
• Any neurological disease other than epilepsy
• Any nutritional disorder
• Any other systemic diseases (including Renal disease, Cardiac arrhythmia)
• Drug intake other than antiepileptic drugs (AED)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnesium add-on	Magnesium	20 children with drug resistant epilepsy will receive oral magnesium sulfate 6 ml per day which equivalent to 400 mg elemental magnesium (Yuen \& Sander, 2012) for 6 months and their regular antiepileptic drugs.
Antiepileptic drugs only	Placebo - Concentrate	20 children with drug resistant epilepsy will receive their regular antiepileptic drugs and placebo for 6 months.

Primary Outcome Measures

Name	Time	Method
IQ improvement	6-months	Change from base line IQ (Wechsler Intelligence Scale-Revised for Children and Adults)
Seizure control	6 months	Change from base line seizure frequency, severity (Chalfont scale) at 6 months.

Trial Locations

Locations (1)

Children's Hospital, Faculty of Medicine, Ain Shams University; 🇪🇬 Cairo, Egypt