Magnesium Therapy on Cerebral Palsy PatientsNCT03471312
Effect of Oral Magnesium Therapy on Constipation on Cerebral Palsy Children
An observational study of Magnesium Therapy on Cerebral Palsy Patients, run by Assiut University.
Trial summary
The aim of this study is to study the therapeutic and adverse effects of oral magnesium sulfate therapy on constipation in children with spastic cerebral palsy suffering from chronic constipation in neuro pediatric unit at Assiut University Hospital. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Magnesium Therapy on Cerebral Palsy Patients
- What is being tested?
- Magnesium
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2018to 30 Dec 2018
- Phase
- Observational
- 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 1 month to 18 years
- All sexes
- Child, Adult
Study population: cerebral palsy patients in the neuro pediatric unit, at Assiut University Children's Hospital
Who may be able to join
- Patients diagnosed as cerebral palsy
- Age below18 year
- Presence of constipation according to ROME criteria
Who cannot join
- Patients with cardiac problem
- Patients with renal problem
- Patients with GIT problem or chronic diarrhea
Trial locations and contacts
No sites are listed yet.
ahlam badawi contact
About this study
Official title: Effect of Oral Magnesium Therapy on Constipation on Children With Cerebral Palsy
The aim of this study is to study the therapeutic and adverse effects of oral magnesium sulfate therapy on constipation in children with spastic cerebral palsy suffering from chronic constipation in neuro pediatric unit at Assiut University Hospital.
Read the detailed description
Children with cerebral palsy (CP) often experience many comorbidities such as constipation,which is considered a frequent problem in spastic (cp)children .It occurs due to reduced mobility, difficulties in feeding and as a side effect of many muscle relaxing medications.It is estimated that 74% of children with cerebral palsy suffer from constipation ,which necessitates use of laxatives. Magnesium sulfate has a famous role as being an osmotic laxative,which is the first step in the pharmacological treatment of constipation
- Mechanism of action of mg sulphate: They are poorly absorbed by the intestinal wall, which leads to intraluminal accumulation of hyperosmolar particles. This stimulates retention of water in the intestinal lumen, softening the stools and increasing peristalsis through intestinal distension. It acts by accelerating small intestinal transit both in fasting and in fed state and it tends to increase the frequency and weight of stools, compared with placebo.In addition ,It increases intraluminal secretion of cholecystokinin and increases nitric oxide (NO) release.
- Side effects of mg sulphate: Reducing the intestinal absorption of fat, protein and carbohydrates following solid meal ingestion
- other drugs used as laxative in cp and there side effects:
- Lactulose: it can lead to distention, bloating and excess flatus. In some individuals these side-effects may limit the use of this product.
- Glycerin: is another small molecule that can exert osmotic activity in the colon. It is not absorbed by the colon and is used as a suppository to draw water into the rectum to produce a bowel movement. It is well absorbed by the small intestine, and hence cannot be taken by oral route.
- The aim of this study is to study the therapeutic and adverse effects of oral magnesium sulfate therapy on constipation in children with spastic cerebral palsy suffering from chronic constipation in neuro pediatric unit at Assiut University Hospital.
- Being tested
- Magnesium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnesiumDrug
Also called placebo
magnesium therapy
| Study group | Role | What they receive |
|---|---|---|
| treated with magnesium therapy | will receive magnesium sulphate 10 mg \kg \day as a single oral dose for one month duration Receives: Drug: Magnesium | |
| treated with placebo drug | will receive placebo drug Receives: Drug: Magnesium |
What is being measured
The primary outcome is the main question the study is designed to answer.
EVALUATE THE EFFECT OF ORAL MAGNESIUM THERAPY ON CONSTIPATION IN CHILDREN WITH CEREBRAL PALSY BY A QUESTIONNAIRE
Evaluate the effect of oral magnesium therapy on constipation in children with spastic cerebral palsy suffering from chronic constipation in neuro pediatric unit at assiut university hospital by comparison of the percentage of improving cases in the 2 groups (first group using oral magnesium therapy . second group using placebo) by a questionnaire asking about amount , frequency and nature of stool
Measured: baseline
Secondary outcomes (1)
Evaluate the main side effect of oral magnesium therapy (Diarrhea)
Evaluate the main side effect of oral magnesium therapy (Diarrhea) on constipation in children with spastic cerebral palsy suffering from chronic constipation in neuro pediatric unit at assiut university hospital by a questionnaire asking about amount , frequency and nature of stool
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start1 May 2018 (estimated)
- Primary completion30 Oct 2018 (estimated)
- Study completion30 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnesium Therapy on Cerebral Palsy PatientsStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NAMostafa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471312
- Sponsor's protocol ID
- constipation on cp patients
- Status last verified
- Mar 2018
- First submitted
- 10 Mar 2018
- Last updated
- 20 Mar 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Magnesium Therapy on Constipation on Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03471312
- Acronym / sponsor ID
- constipation on cp patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (estimated)
- Primary completion
- 30 Oct 2018 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 20 Mar 2018 (actual)
- 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.
The aim of this study is to study the therapeutic and adverse effects of oral magnesium sulfate therapy on constipation in children with spastic cerebral palsy suffering from chronic constipation in neuro pediatric unit at Assiut University Hospital.
Detailed description
Children with cerebral palsy (CP) often experience many comorbidities such as constipation,which is considered a frequent problem in spastic (cp)children .It occurs due to reduced mobility, difficulties in feeding and as a side effect of many muscle relaxing medications.It is estimated that 74% of children with cerebral palsy suffer from constipation ,which necessitates use of laxatives. Magnesium sulfate has a famous role as being an osmotic laxative,which is the first step in the pharmacological treatment of constipation
- Mechanism of action of mg sulphate: They are poorly absorbed by the intestinal wall, which leads to intraluminal accumulation of hyperosmolar particles. This stimulates retention of water in the intestinal lumen, softening the stools and increasing peristalsis through intestinal distension. It acts by accelerating small intestinal transit both in fasting and in fed state and it tends to increase the frequency and weight of stools, compared with placebo.In addition ,It increases intraluminal secretion of cholecystokinin and increases nitric oxide (NO) release.
- Side effects of mg sulphate: Reducing the intestinal absorption of fat, protein and carbohydrates following solid meal ingestion
- other drugs used as laxative in cp and there side effects:
- Lactulose: it can lead to distention, bloating and excess flatus. In some individuals these side-effects may limit the use of this product.
- Glycerin: is another small molecule that can exert osmotic activity in the colon. It is not absorbed by the colon and is used as a suppository to draw water into the rectum to produce a bowel movement. It is well absorbed by the small intestine, and hence cannot be taken by oral route.
- The aim of this study is to study the therapeutic and adverse effects of oral magnesium sulfate therapy on constipation in children with spastic cerebral palsy suffering from chronic constipation in neuro pediatric unit at Assiut University Hospital.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treated with magnesium therapy | – | Drug: Magnesiumwill receive magnesium sulphate 10 mg \kg \day as a single oral dose for one month duration |
| treated with placebo drug | – | Drug: Magnesiumwill receive placebo drug |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- cerebral palsy patients in the neuro pediatric unit, at Assiut University Children's Hospital
Key inclusion criteria (3 listed)
- Patients diagnosed as cerebral palsy
- Age below18 year
- Presence of constipation according to ROME criteria
Key exclusion criteria (3 listed)
- Patients with cardiac problem
- Patients with renal problem
- Patients with GIT problem or chronic diarrhea
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 |
|---|---|---|
| MagnesiumAlso: placebomagnesium therapy | Drug | treated with magnesium therapy, treated with placebo drug |
Primary outcome
EVALUATE THE EFFECT OF ORAL MAGNESIUM THERAPY ON CONSTIPATION IN CHILDREN WITH CEREBRAL PALSY BY A QUESTIONNAIRE
Time frame: baseline
Evaluate the effect of oral magnesium therapy on constipation in children with spastic cerebral palsy suffering from chronic constipation in neuro pediatric unit at assiut university hospital by comparison of the percentage of improving cases in the 2 groups (first group using oral magnesium therapy . second group using placebo) by a questionnaire asking about amount , frequency and nature of stool
1 secondary outcome
Evaluate the main side effect of oral magnesium therapy (Diarrhea)
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
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.
ahlam badawi contact
Questions about this trial
What is this clinical trial studying?
An observational study of Magnesium Therapy on Cerebral Palsy Patients, run by Assiut University.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nermeen abdelmageed (01145325756 ext. 00+20, nemo.memo19.nm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EVALUATE THE EFFECT OF ORAL MAGNESIUM THERAPY ON CONSTIPATION IN CHILDREN WITH CEREBRAL PALSY BY A QUESTIONNAIRE (time frame: baseline). 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 20 Mar 2018.