Cerebral PalsyNCT02510222
Magnesium Therapy in Children With Cerebral Palsy
A study testing Oral magnesium sulfate in people with Cerebral Palsy, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Oral magnesium sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- May 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
Egypt1 site
Children's Hospital, Faculty of Medicine, Ain Shams University
Cairo, Cairo Governorate, 11381
About this study
Official title: Effect of Magnesium Therapy on Spasticity and Constipation in Children With Cerebral Palsy
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.
Read the detailed 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.
- Conditions
- Cerebral Palsy
- Being tested
- Oral magnesium sulfate, Placebo
- Keywords
- child
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral magnesium sulfateDietary 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 .
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in muscle tone evaluated by Modified Ashworth Index and constipation ROM-lll criteria
Measured: 1 month
Secondary outcomes (1)
Improvement in H/M ratio in H-reflex by electrophysiologic assessment
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahar M.A. Hassanein, MD, Ain Shams University
- Investigators
- Sahar MA Hassanein, PhD, MD, Principal investigator, Pediatric department, Faculty of Medicine , Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510222
- Sponsor's protocol ID
- Pediatrics MS
- Status last verified
- Feb 2017
- First submitted
- 26 Jul 2015
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Magnesium Therapy on Spasticity and Constipation in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02510222
- Acronym / sponsor ID
- Pediatrics MS
- Conditions
- Cerebral Palsy
- Keywords
- child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 29 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Magnesium sulfate | Experimental | Dietary Supplement: Oral magnesium sulfateMagnesium 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 |
| Control | Placebo comparator | Other: PlaceboFifty children with cerebral palsy will be treated with conventional therapy as physiotherapy. They will receive placebo. |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral magnesium sulfateMagnesium 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 . | Dietary supplement | Oral Magnesium sulfate |
| Placebo | Other | Control |
Primary outcome
Decrease in muscle tone evaluated by Modified Ashworth Index and constipation ROM-lll criteria
Time frame: 1 month
1 secondary outcome
Improvement in H/M ratio in H-reflex by electrophysiologic assessment
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sahar MA Hassanein, PhD, MD principal investigator
Pediatric department, Faculty of Medicine , Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral magnesium sulfate in people with Cerebral Palsy, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in muscle tone evaluated by Modified Ashworth Index and constipation ROM-lll criteria (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2017.