Magnesium Therapy in Children With Cerebral Palsy

Ain Shams University

Status: Completed

Conditions: Cerebral Palsy

Treatments: Dietary Supplement: Oral magnesium sulfate; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02510222

Pediatrics MS

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 64 patients

Sex: All

Ages: 6 months to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age below12 years.
• Presence of spasticity without joint contracture Spasticity is defined as velocity dependent, increased resistance to passive muscle stretch.
• Acceptance of caregivers to participate in the study and signing the written consent.
• Constipation will be defined according to Rome lll criteria.presence of at least 2 of the following 2 motions week, history of painful or hard bowel movement, presence of large diameter stools that stools that may obstruct the toilets (Burgers et al., 2012).

Exclusion criteria

• Severe growth retardation (Below the 10th centile for weight and length charts children with cerebral palsy).
• Gastrostomy tube feeding.
• Joint contractures.
• Congenital malformations.
• Suspected inborn error of metabolism.
• Suspected inherited neurologic disease.
• Care giver's refusal to participate in the study.
• Occurrence of side effects of oral magnesium sulfate.
• Patients with cardiac, renal, GIT problem or chronic diarrhea.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 2 patient groups, including a placebo group

Oral Magnesium sulfate

Experimental group

Description:

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

Treatment:

Dietary Supplement: Oral magnesium sulfate

Control

Placebo Comparator group

Description:

Fifty children with cerebral palsy will be treated with conventional therapy as physiotherapy. They will receive placebo.

Treatment:

Other: Placebo