LIVER CIRRHOSISPhase 4NCT01894867
Magnesium in Liver Cirrhosis
A Phase 4 study testing magnesium in people with LIVER CIRRHOSIS, run by Meir Medical Center at 1 site in Israel.
Trial summary
Several studies have shown in patients magnesium deficiency with liver cirrhosis. Patients with liver cirrhosis showed considerably reduced muscle strength and muscle magnesium. We suggest addition of magnesium to patients with established cirrhosis in order to reduce the neuromuscular and neuropsychiatric… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- LIVER CIRRHOSIS
- What is being tested?
- magnesium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2013to Apr 2014
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with liver cirrhosis
Who cannot join
- pregnant women
- Patients with acute or chronic renal failure (cr>1.5)
- Congestive heart failure NYHA 3-4
- Patient with active cancer
- Patients with dementia or mental retardation
Trial locations and contacts
1 site in 1 country.
yona kitay, MD contact
Israel1 site
liver outpatients clinic, Meir medical center
Kfar Saba, Israel
keren cohen, MD, 97297471560, keren.cohen@clalit.org.il
keren cohen, MD
About this study
Official title: Magnesium Deficiency in Cirrhotic Patients
Several studies have shown in patients magnesium deficiency with liver cirrhosis.
Patients with liver cirrhosis showed considerably reduced muscle strength and muscle magnesium.
We suggest addition of magnesium to patients with established cirrhosis in order to reduce the neuromuscular and neuropsychiatric manifestations of chronic liver disease.
Read the detailed description
Magnesium is the fourth most abundant cation in the body and plays an important physiological role in many of its functions.
There are no readily available and easy methods to assess magnesium status but it is estimated that magnesium deficiency is a common problem.
Magnesium deficiency can cause a wide variety of features including hypocalcaemia, hypokalaemia and cardiac and neurological manifestations. Chronic low magnesium state has been associated with a number of chronic diseases including diabetes, hypertension, coronary heart disease, and osteoporosis.
There are not enough studies on magnesium status in chronic cirrhotics who may be in depletion. However , several studies have shown in patients magnesium deficiency with liver cirrhosis. Patients with liver cirrhosis showed considerably reduced muscle strength and muscle Mg . Magnesium may have a role in the neuromuscular and neuropsychiatric manifestations of chronic liver disease (hepatic encephalopathy and muscle cramps).
The use of magnesium as a therapeutic agent in asthma, myocardial infarction, and pre-eclampsia is also discussed. We suggest addition of magnesium to patients with established cirrhosis in order to reduce the neuromuscular and neuropsychiatric manifestations of chronic liver disease.
- Conditions
- LIVER CIRRHOSIS
- Being tested
- magnesium, Placebo
- Keywords
- LIVER CIRRHOSIS, MAGNESIUM, MINIMAL ENCEPHALOPATHY, MUSCLE WEAKNESS
- Medical subject headings
- Liver Cirrhosis, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnesiumDietary supplement
Also called magnesium oxide
supply magnesium oxide for 6 weeks
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| magnesium | Experimental | will get magnesium for 6 weeks Receives: Dietary Supplement: magnesium |
| placebo | Placebo comparator | will get placebo for 6 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in minimal hepatic encephalopathy
Measured: 6 weeks
Secondary outcomes (1)
change in muscle weakness
Measured: 6 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LIVER CIRRHOSISStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- keren cohen, MD, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01894867
- Sponsor's protocol ID
- MMC13247-12CTIL
- Status last verified
- Jun 2013
- First submitted
- 4 Jul 2013
- Last updated
- 12 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium Deficiency in Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT01894867
- Acronym / sponsor ID
- MMC13247-12CTIL
- Conditions
- LIVER CIRRHOSIS
- Keywords
- LIVER CIRRHOSIS, MAGNESIUM, MINIMAL ENCEPHALOPATHY, MUSCLE WEAKNESS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Apr 2014 (estimated)
- First posted
- 10 Jul 2013 (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.
Several studies have shown in patients magnesium deficiency with liver cirrhosis.
Patients with liver cirrhosis showed considerably reduced muscle strength and muscle magnesium.
We suggest addition of magnesium to patients with established cirrhosis in order to reduce the neuromuscular and neuropsychiatric manifestations of chronic liver disease.
Detailed description
Magnesium is the fourth most abundant cation in the body and plays an important physiological role in many of its functions.
There are no readily available and easy methods to assess magnesium status but it is estimated that magnesium deficiency is a common problem.
Magnesium deficiency can cause a wide variety of features including hypocalcaemia, hypokalaemia and cardiac and neurological manifestations. Chronic low magnesium state has been associated with a number of chronic diseases including diabetes, hypertension, coronary heart disease, and osteoporosis.
There are not enough studies on magnesium status in chronic cirrhotics who may be in depletion. However , several studies have shown in patients magnesium deficiency with liver cirrhosis. Patients with liver cirrhosis showed considerably reduced muscle strength and muscle Mg . Magnesium may have a role in the neuromuscular and neuropsychiatric manifestations of chronic liver disease (hepatic encephalopathy and muscle cramps).
The use of magnesium as a therapeutic agent in asthma, myocardial infarction, and pre-eclampsia is also discussed. We suggest addition of magnesium to patients with established cirrhosis in order to reduce the neuromuscular and neuropsychiatric manifestations of chronic liver disease.
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 |
|---|---|---|
| magnesium | Experimental | Dietary Supplement: magnesiumwill get magnesium for 6 weeks |
| placebo | Placebo comparator | Dietary Supplement: Placebowill get placebo for 6 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with liver cirrhosis
Key exclusion criteria (5 listed)
- pregnant women
- Patients with acute or chronic renal failure (cr>1.5)
- Congestive heart failure NYHA 3-4
- Patient with active cancer
- Patients with dementia or mental retardation
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: magnesium oxidesupply magnesium oxide for 6 weeks | Dietary supplement | magnesium |
| Placebo | Dietary supplement | placebo |
Primary outcome
change in minimal hepatic encephalopathy
Time frame: 6 weeks
1 secondary outcome
change in muscle weakness
Time frame: 6 weeks after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2013.
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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.
yona kitay, MD contact
keren cohen, MD principal investigator
Meir Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing magnesium in people with LIVER CIRRHOSIS, run by Meir Medical Center at 1 site in Israel.
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 1 inclusion and 5 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 12 Jul 2013. 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 Israel. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 keren cohen, MD (972522237442, kerenc03@walla.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in minimal hepatic encephalopathy (time frame: 6 weeks). 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 12 Jul 2013.