NCT02982824

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 6, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

May 9, 2017

Status Verified

December 1, 2016

Enrollment Period

5 months

First QC Date

November 22, 2016

Last Update Submit

May 7, 2017

Conditions

Drug Resistant Epilepsy

Keywords

ChildrenIQIdiopathic epilepsyMagnesium supplementationSeizure controlChalfont score

Outcome Measures

Primary Outcomes (2)

  • Seizure control

    Change from base line seizure frequency, severity (Chalfont scale) at 6 months.

    6 months

  • IQ improvement

    Change from base line IQ (Wechsler Intelligence Scale-Revised for Children and Adults)

    6-months

Study Arms (3)

Magnesium add-on

EXPERIMENTAL

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

Antiepileptic drugs only

PLACEBO COMPARATOR

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

Drug: Placebo - Concentrate

Healthy controls

NO INTERVENTION

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

Interventions

MagnesiumDIETARY_SUPPLEMENT

Oral magnesium

Magnesium add-on
Placebo - ConcentrateDRUG

Placebo will be given

Antiepileptic drugs only

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with drug resistant idiopathic epilepsy

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Cairo, 11381, Egypt

Location

Related Publications (2)

  • 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.

    PMID: 16788707BACKGROUND

  • 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.

    PMID: 26313363BACKGROUND

MeSH Terms

Conditions

Drug Resistant Epilepsy

Interventions

Magnesium

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetals, LightMetals

Study Officials

  • Sahar MA Hassanein, PhD. MD

    Pediatrics, Faculty of Medicine, Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics and Head of Pediatric Neurology Unit, Children's

Study Record Dates

First Submitted

November 22, 2016

First Posted

December 6, 2016

Study Start

September 1, 2016

Primary Completion

February 1, 2017

Study Completion

March 1, 2017

Last Updated

May 9, 2017

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will share

Locations

EG(1)