Magnesium Therapy in Children With Cerebral Palsy
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|ClinicalTrials.gov Identifier: NCT02510222|
Recruitment Status : Completed
First Posted : July 29, 2015
Last Update Posted : February 10, 2017
This study is considered a pilot exploratory study. Intervention, prospective, double-armed, randomized, placebo-control clinical trial.
The therapeutic effect of oral Magnesium sulfate on spasticity and constipation will be studied.
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy||Dietary Supplement: Oral magnesium sulfate Other: Placebo||Not Applicable|
Spasticity and constipation are major problems hindering improvement in motor development in children with cerebral palsy.
Decreasing spasticity will have a positive effect on motor development and quality of life for the child and his family.
The aim is to study the therapeutic and adverse effects of oral magnesium sulfate therapy on spasticity and constipation in infants and children with cerebral palsy.
Hundred children with spastic cerebral palsy will be randomized to either intervention group n=50 will be treated with magnesium sulfate 4% orally for 28 days to treat spasticity and constipation in addition to their conventional treatment, or placebo group n=50 will receive conventional treatment and placebo.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Effect of Magnesium Therapy on Spasticity and Constipation in Children With Cerebral Palsy|
|Study Start Date :||May 2015|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Experimental: Oral Magnesium sulfate
Magnesium sulphate 4% concentration orally ( 65 mg per day for children one to three years of age; 110 mg per day for children four to eight years of age; 350 mg per day for children older than eight years) for 1 month
Dietary Supplement: Oral magnesium sulfate
Magnesium sulfate 4% concentration in a dose of 65 mg/day for infants and children aged 1-3 years , 110 mg/day for those 3-8 years and 350 mg/day for those above 9 years .Each 1 ml of the magnesium sulfate used contains 0.325 mEq (milliequivalent) of elemental magnesium which equals to 4 mg elemental magnesium .
Placebo Comparator: Control
Fifty children with cerebral palsy will be treated with conventional therapy as physiotherapy. They will receive placebo.
- Decrease in muscle tone evaluated by Modified Ashworth Index and constipation ROM-lll criteria [ Time Frame: 1 month ]
- Improvement in H/M ratio in H-reflex by electrophysiologic assessment [ Time Frame: 1 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02510222
|Children's Hospital, Faculty of Medicine, Ain Shams University|
|Cairo, Egypt, 11381|
|Principal Investigator:||Sahar MA Hassanein, PhD, MD||Pediatric department, Faculty of Medicine , Ain Shams University|