Healthy SubjectsPhase 4NCT00994006
The Absorption of Magnesium Oxide Compared to Citrate in Healthy Subjects
A Phase 4 study testing Magnesium oxide and Magnesium citrate in people with Healthy Subjects and Hypomagnesemia, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The magnesium food content in the Western world is consistently reducing. Hypomagnesemia is common in hospitalized patients, especially in the elderly with coronary artery disease (CAD) and/or those with chronic heart failure. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Hypomagnesemia
- What is being tested?
- Magnesium oxide and Magnesium citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2010to Mar 2011
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 20-70 years
- Healthy subjects
Who cannot join
- Chest pain
- Diabetes mellitus
- Documented coronary artery disease
- Asthma or any lung disease
- Chronic diarrhea
- Chronic renal failure (serum creatinine> 3 mg/dL)
Show all 19Show fewer
- Hypo or hyperthyroidism
- Heart failure
- On any chronic therapy/medications
- Malabsorption
- AV block
- Pacemaker
- Any malignancy
- Obesity > 30 kg/m2 body mass index
- Smokers
- Pregnancy
- Alcohol or drug abuse
- Any chronic inflammation
- Refuse to sign inform consent
Trial locations and contacts
1 site in 1 country.
Israel1 site
The Leviev Heart Center, Chaim Sheba Medical Center
Tel Hashomer, Ramat Gan, 52621
About this study
Official title: The Absorption of Supplemental Magnesium Oxide Compared to Magnesium Citrate in Healthy Subjects With no Apparent Heart Disease
The magnesium food content in the Western world is consistently reducing. Hypomagnesemia is common in hospitalized patients, especially in the elderly with coronary artery disease (CAD) and/or those with chronic heart failure. Hypomagnesemia is associated with increased incidence of diabetes mellitus, metabolic syndrome, mortality rate from coronary artery disease (CAD) and all cause. Magnesium supplementation improves myocardial metabolism, inhibits calcium accumulation and myocardial cell death; it improves vascular tone, peripheral vascular resistance, afterload and cardiac output, reduces cardiac arrhythmias and improves lipid metabolism. Magnesium also reduces vulnerability to oxygen-derived free radicals, improves human endothelial function and inhibits platelet function, including platelet aggregation and adhesion. The data regarding the absorption difference between supplemental magnesium oxide and magnesium citrate in humans is spare.
Read the detailed description
Two oral preparations of magnesium are available in Israel:
- Magnesium Diasporal (magnesium citrate, elemental magnesium 98.6 mg), PROTINA GMBH, ISMANING, Germany
- Magnox 520 TM (magnesium oxide, 520 mg elemental magnesium), Naveh Pharma Ltd., Israel.
The data regarding the absorption difference between the two supplemental magnesium preparations (magnesium oxide and magnesium citrate) in humans is spare.
Primary objective: To find out the absorption of magnesium citrate compared to magnesium oxide in healthy subjects with no apparent heart disease.
- Conditions
- Healthy Subjects, Hypomagnesemia
- Being tested
- Magnesium oxide, Magnesium citrate
- Keywords
- Magnesium, nutrition, platelets, aggregation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium oxideDietary supplement
Also called Magnox 520 TM
520 mg of elemental magnesium q.d.
Magnesium citrateDietary supplement
Also called Magnesium Diasporal
Magnesium citrate , 98.6 mg of elemental magnesium t.i.d.
| Study group | Role | What they receive |
|---|---|---|
| Magnesium oxide tables | Active comparator | Subjects will be instructed to take Magnox 520 qd Receives: Dietary Supplement: Magnesium oxide |
| Magnesium citrate tablets | Active comparator | Subjects will be instructed to take magnesium diasporal tablets t.i.d. Receives: Dietary Supplement: Magnesium citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracellular magnesium levels will be assessed
Measured: 30-day
Secondary outcomes (1)
Platelet function tests
Measured: 30-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startJan 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Michael Shechter, MD, MA, Principal investigator, The Leviev Heart Center, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994006
- Sponsor's protocol ID
- SHEBA-7339-09-SMC
- Status last verified
- May 2011
- First submitted
- 11 Oct 2009
- Last updated
- 4 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Shechter M. Magnesium and cardiovascular system. Magnes Res. 2010 Jun;23(2):60-72. doi: 10.1684/mrh.2010.0202. Epub 2010 Mar 31.
PubMed 20353903Shechter M, Saad T, Shechter A, Koren-Morag N, Silver BB, Matetzky S. Comparison of magnesium status using X-ray dispersion analysis following magnesium oxide and magnesium citrate treatment of healthy subjects. Magnes Res. 2012 Mar 1;25(1):28-39. doi: 10.1684/mrh.2012.0305.
PubMed 22433473
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Absorption of Supplemental Magnesium Oxide Compared to Magnesium Citrate in Healthy Subjects With no Apparent Heart Disease
- ClinicalTrials.gov ID
- NCT00994006
- Acronym / sponsor ID
- SHEBA-7339-09-SMC
- Conditions
- Healthy Subjects, Hypomagnesemia
- Keywords
- Magnesium, nutrition, platelets, aggregation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jan 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 14 Oct 2009 (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.
The magnesium food content in the Western world is consistently reducing. Hypomagnesemia is common in hospitalized patients, especially in the elderly with coronary artery disease (CAD) and/or those with chronic heart failure. Hypomagnesemia is associated with increased incidence of diabetes mellitus, metabolic syndrome, mortality rate from coronary artery disease (CAD) and all cause. Magnesium supplementation improves myocardial metabolism, inhibits calcium accumulation and myocardial cell death; it improves vascular tone, peripheral vascular resistance, afterload and cardiac output, reduces cardiac arrhythmias and improves lipid metabolism. Magnesium also reduces vulnerability to oxygen-derived free radicals, improves human endothelial function and inhibits platelet function, including platelet aggregation and adhesion. The data regarding the absorption difference between supplemental magnesium oxide and magnesium citrate in humans is spare.
Detailed description
Two oral preparations of magnesium are available in Israel:
- Magnesium Diasporal (magnesium citrate, elemental magnesium 98.6 mg), PROTINA GMBH, ISMANING, Germany
- Magnox 520 TM (magnesium oxide, 520 mg elemental magnesium), Naveh Pharma Ltd., Israel.
The data regarding the absorption difference between the two supplemental magnesium preparations (magnesium oxide and magnesium citrate) in humans is spare.
Primary objective: To find out the absorption of magnesium citrate compared to magnesium oxide in healthy subjects with no apparent heart disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium oxide tables | Active comparator | Dietary Supplement: Magnesium oxideSubjects will be instructed to take Magnox 520 qd |
| Magnesium citrate tablets | Active comparator | Dietary Supplement: Magnesium citrateSubjects will be instructed to take magnesium diasporal tablets t.i.d. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 20-70 years
- Healthy subjects
Key exclusion criteria (19 listed)
- Chest pain
- Diabetes mellitus
- Documented coronary artery disease
- Asthma or any lung disease
- 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 |
|---|---|---|
| Magnesium oxideAlso: Magnox 520 TM520 mg of elemental magnesium q.d. | Dietary supplement | Magnesium oxide tables |
| Magnesium citrateAlso: Magnesium DiasporalMagnesium citrate , 98.6 mg of elemental magnesium t.i.d. | Dietary supplement | Magnesium citrate tablets |
Primary outcome
Intracellular magnesium levels will be assessed
Time frame: 30-day
1 secondary outcome
Platelet function tests
Time frame: 30-day
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 4 May 2011.
- Background: PubMed 20353903Shechter M. Magnesium and cardiovascular system. Magnes Res. 2010 Jun;23(2):60-72. doi: 10.1684/mrh.2010.0202. Epub 2010 Mar 31.
- Derived from this study: PubMed 22433473Shechter M, Saad T, Shechter A, Koren-Morag N, Silver BB, Matetzky S. Comparison of magnesium status using X-ray dispersion analysis following magnesium oxide and magnesium citrate treatment of healthy subjects. Magnes Res. 2012 Mar 1;25(1):28-39. doi: 10.1684/mrh.2012.0305.
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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.
Michael Shechter, MD, MA principal investigator
The Leviev Heart Center, Sheba 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 oxide and Magnesium citrate in people with Healthy Subjects and Hypomagnesemia, run by Sheba 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 2 inclusion and 19 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 4 May 2011. 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. 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?
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?
Intracellular magnesium levels will be assessed (time frame: 30-day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00994006, which also lists 2 linked publications.
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 4 May 2011.