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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Antiepileptic drugs only | Placebo Comparator | 20 children with drug resistant epilepsy will receive their regular antiepileptic drugs and placebo for 6 months. |
|
| Healthy controls | No Intervention | To asses serum magnesium level for comparison with the intervention group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium | Dietary Supplement | Oral magnesium |
| |
| Placebo - Concentrate |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sahar MA Hassanein, PhD. MD | Pediatrics, Faculty of Medicine, Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital, Faculty of Medicine, Ain Shams University | Cairo | 11381 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16788707 | Background | 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. | |
| 26313363 | Background | 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. |
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| ID | Term |
|---|---|
| D000069279 | Drug Resistant Epilepsy |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008274 | Magnesium |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
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| Drug |
Placebo will be given |
|
| D008670 |
| Metals |