Effect of Magnesium Supplementation for Children With Drug Resistant Idiopathic Epilepsy

Drug Resistant Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02982824
• Other study ID #: FMASU M.S 20/2016
• Status: Completed
• Phase: N/A
• First received: November 22, 2016
• Last updated: May 7, 2017
• Start date: September 2016
• Est. completion date: March 2017

Study information

• Verified date: December 2016
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

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)

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy

Intervention

Dietary Supplement:
• Magnesium
Oral magnesium

Drug:
• Placebo - Concentrate
Placebo will be given

Locations

Country	Name	City	State
Egypt	Children's Hospital, Faculty of Medicine, Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & 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. Epub 2006 Jun 21. — View 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. Review. — View Citation

Outcome

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