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Effect of Magnesium Supplementation for Children With Drug Resistant Idiopathic Epilepsy

Primary Purpose

Drug Resistant Epilepsy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Magnesium
Placebo - Concentrate
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug Resistant Epilepsy focused on measuring Children, IQ, Idiopathic epilepsy, Magnesium supplementation, Seizure control, Chalfont score

Eligibility Criteria

6 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Magnesium add-on

Antiepileptic drugs only

Healthy controls

Arm Description

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.

20 children with drug resistant epilepsy will receive their regular antiepileptic drugs and placebo for 6 months.

To asses serum magnesium level for comparison with the intervention group.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 22, 2016
Last Updated
May 7, 2017
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT02982824
Brief Title
Effect of Magnesium Supplementation for Children With Drug Resistant Idiopathic Epilepsy
Official Title
Magnesium Supplementation for Children With Drug Resistant Idiopathic Epilepsy: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Resistant Epilepsy
Keywords
Children, IQ, Idiopathic epilepsy, Magnesium supplementation, Seizure control, Chalfont score

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnesium add-on
Arm Type
Experimental
Arm Description
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.
Arm Title
Antiepileptic drugs only
Arm Type
Placebo Comparator
Arm Description
20 children with drug resistant epilepsy will receive their regular antiepileptic drugs and placebo for 6 months.
Arm Title
Healthy controls
Arm Type
No Intervention
Arm Description
To asses serum magnesium level for comparison with the intervention group.
Intervention Type
Dietary Supplement
Intervention Name(s)
Magnesium
Intervention Description
Oral magnesium
Intervention Type
Drug
Intervention Name(s)
Placebo - Concentrate
Intervention Description
Placebo will be given
Primary Outcome Measure Information:
Title
Seizure control
Description
Change from base line seizure frequency, severity (Chalfont scale) at 6 months.
Time Frame
6 months
Title
IQ improvement
Description
Change from base line IQ (Wechsler Intelligence Scale-Revised for Children and Adults)
Time Frame
6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sahar MA Hassanein, PhD. MD
Organizational Affiliation
Pediatrics, Faculty of Medicine, Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital, Faculty of Medicine, Ain Shams University
City
Cairo
ZIP/Postal Code
11381
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
16788707
Citation
Gontijo-Amaral C, Ribeiro MA, Gontijo LS, Condino-Neto A, Ribeiro JD. Oral magnesium supplementation in asthmatic children: a double-blind randomized placebo-controlled trial. Eur J Clin Nutr. 2007 Jan;61(1):54-60. doi: 10.1038/sj.ejcn.1602475. Epub 2006 Jun 21.
Results Reference
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PubMed Identifier
26313363
Citation
Osborn KE, Shytle RD, Frontera AT, Soble JR, Schoenberg MR. Addressing potential role of magnesium dyshomeostasis to improve treatment efficacy for epilepsy: A reexamination of the literature. J Clin Pharmacol. 2016 Mar;56(3):260-5. doi: 10.1002/jcph.626. Epub 2015 Oct 26.
Results Reference
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Learn more about this trial

Effect of Magnesium Supplementation for Children With Drug Resistant Idiopathic Epilepsy

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