Effect of Magnesium Supplementation for Children With Drug Resistant Idiopathic Epilepsy

May 7, 2017 updated by: Sahar M.A. Hassanein, MD, Ain Shams University

Magnesium Supplementation for Children With Drug Resistant Idiopathic Epilepsy: A Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

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
      • Cairo, Egypt, 11381
        • Children's Hospital, Faculty of Medicine, Ain Shams University

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

4 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magnesium add-on
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.
Dietary supplement: Magnesium
Oral magnesium
Placebo Comparator: Antiepileptic drugs only
20 children with drug resistant epilepsy will receive their regular antiepileptic drugs and placebo for 6 months.
Drug: Placebo - Concentrate
Placebo will be given
No Intervention: Healthy controls
To asses serum magnesium level for comparison with the intervention group.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Sahar MA Hassanein, PhD. MD, Pediatrics, Faculty of Medicine, Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

September 1, 2016

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

November 22, 2016

First Submitted That Met QC Criteria

December 1, 2016

First Posted (Estimate)

December 6, 2016

Study Record Updates

Last Update Posted (Actual)

May 9, 2017

Last Update Submitted That Met QC Criteria

May 7, 2017

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU M.S 20/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

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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