Magnesium Therapy in Children With Cerebral Palsy

NCT02510222 | Completed DMC

• 1 other identifier: Pediatrics MS
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Palsy

Keywords

child

Outcome Measures

Primary Outcomes (1)

• Decrease in muscle tone evaluated by Modified Ashworth Index and constipation ROM-lll criteria

  1 month

Secondary Outcomes (1)

• Improvement in H/M ratio in H-reflex by electrophysiologic assessment

  1 month

Study Arms (2)

Oral Magnesium sulfate

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Oral magnesium sulfate DIETARY_SUPPLEMENT

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 .

Oral Magnesium sulfate

Placebo OTHER

Control

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

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

Cairo, Cairo Governorate, 11381, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Sahar MA Hassanein, PhD, MD

  Pediatric department, Faculty of Medicine , Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics , Faculty of Medicine

Study Record Dates

• First Submitted: July 26, 2015
• First Posted: July 29, 2015
• Study Start: May 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: February 10, 2017

Record last verified: 2017-02

Locations

EG (1)