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OpenTrials
Completed

NCT Number: NCT02982824

Effect of Magnesium Supplementation for Children With Drug Resistant Idiopathic Epilepsy

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.

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Key information

Conditions

Drug Resistant Epilepsy Brain Diseases Central Nervous System Diseases Epilepsy Nervous System Diseases

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Cairo, 11381, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

magnesium

Dietary Supplement

Oral magnesium

Placebo - Concentrate

Drug

Placebo will be given

Primary outcomes

  1. Seizure control

    Time frame: 6 months

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

  2. IQ improvement

    Time frame: 6-months

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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 6, 2016
Registry last updated
May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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