ObesityNCT02966912
Magnesium Supplementation for Primary Prevention of Heart Failure in Obesity
A study testing 400 mg of Magnesium Oxide twice daily for 24 weeks and Open label (none) in people with Obesity, run by Providence VA Medical Center at 1 site in United States.
Trial summary
The objective of this study is to investigate whether nutritional supplementation with magnesium can improve cardiovascular structure and function in participants with obesity - with a long-term goal of preventing clinical heart failure. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- 400 mg of Magnesium Oxide twice daily for 24 weeks and Open label (none)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Sep 2019
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index greater than 30 kg/m2
Who cannot join
- History of hospitalization for heart failure (systolic or diastolic);
- Unstable angina or prior myocardial infarction;
- LV ejection fraction <50% on imaging study;
- Valvular heart disease (stenosis or insufficiency) greater than moderate degree;
- Renal dysfunction, serum creatinine >2.5 mg/dL or estimated creatinine clearance <30 mL/min/1.73 m2 (30),
- Pregnant women or actively breastfeeding women
- History of drug supplementation within the last 6 months in which more than 50 miliequivalents per day of supplemental magnesium is contained
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence VA Medical Center
Providence, Rhode Island, 02908
About this study
The objective of this study is to investigate whether nutritional supplementation with magnesium can improve cardiovascular structure and function in participants with obesity - with a long-term goal of preventing clinical heart failure. Specifically, in a randomized open-label pilot study, we will assess whether dietary Magnesium (Mg) supplementation (versus no supplementation) for 24 weeks in obese patients will improve left ventricular (LV) mass.
Read the detailed description
The investigators propose a 24-week therapeutic trial involving 40 participants with obesity from the Providence VA Medical Center without clinical heart failure. 20 participants will be treated with 400 mg of Magnesium Oxide twice daily, while 20 participants will receive no treatment. The trial tests the hypothesis that oral Mg supplementation will improve: LV structure (by LV mass, steatosis, and ECV), LV function (systolic and diastolic), vascular health (systolic blood pressure and aortic pulse wave velocity) and visceral adiposity.
- Conditions
- Obesity
- Being tested
- 400 mg of Magnesium Oxide twice daily for 24 weeks, Open label (none)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
400 mg of Magnesium Oxide twice daily for 24 weeksDietary supplement
Open label (none)Other
| Study group | Role | What they receive |
|---|---|---|
| Magnesium | Experimental | 20 participants will be treated with 400 mg of Magnesium Oxide twice daily Receives: Dietary Supplement: 400 mg of Magnesium Oxide twice daily for 24 weeks |
| Comparator | Active comparator | 20 participants will receive no treatment Receives: Other: Open label (none) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular mass (by cardiac MRI)
Measured: 24 weeks
Left ventricular myocardial triglyceride content (by cardiac MRI)
Measured: 24 weeks
Left ventricular extracellular volume fraction (by cardiac MRI)
Measured: 24 weeks
Secondary outcomes (2)
Systolic blood pressure
Measured: 24 weeks
Aortic pulse wave velocity (by cardiac MRI)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Wen-Chih Wu, Providence VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966912
- Sponsor's protocol ID
- 442702
- Status last verified
- Feb 2023
- First submitted
- 15 Nov 2016
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium Supplementation for Primary Prevention of Heart Failure in Obesity
- ClinicalTrials.gov ID
- NCT02966912
- Acronym / sponsor ID
- 442702
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Providence VA Medical CenterUS federal agency
- Study start
- Nov 2016
- Primary completion
- Mar 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 17 Nov 2016 (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 objective of this study is to investigate whether nutritional supplementation with magnesium can improve cardiovascular structure and function in participants with obesity - with a long-term goal of preventing clinical heart failure. Specifically, in a randomized open-label pilot study, we will assess whether dietary Magnesium (Mg) supplementation (versus no supplementation) for 24 weeks in obese patients will improve left ventricular (LV) mass.
Detailed description
The investigators propose a 24-week therapeutic trial involving 40 participants with obesity from the Providence VA Medical Center without clinical heart failure. 20 participants will be treated with 400 mg of Magnesium Oxide twice daily, while 20 participants will receive no treatment. The trial tests the hypothesis that oral Mg supplementation will improve: LV structure (by LV mass, steatosis, and ECV), LV function (systolic and diastolic), vascular health (systolic blood pressure and aortic pulse wave velocity) and visceral adiposity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium | Experimental | Dietary Supplement: 400 mg of Magnesium Oxide twice daily for 24 weeks20 participants will be treated with 400 mg of Magnesium Oxide twice daily |
| Comparator | Active comparator | Other: Open label (none)20 participants will receive no treatment |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Body mass index greater than 30 kg/m2
Key exclusion criteria (7 listed)
- History of hospitalization for heart failure (systolic or diastolic);
- Unstable angina or prior myocardial infarction;
- LV ejection fraction <50% on imaging study;
- Valvular heart disease (stenosis or insufficiency) greater than moderate degree;
- Renal dysfunction, serum creatinine >2.5 mg/dL or estimated creatinine clearance <30 mL/min/1.73 m2 (30),
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 |
|---|---|---|
| 400 mg of Magnesium Oxide twice daily for 24 weeks | Dietary supplement | Magnesium |
| Open label (none) | Other | Comparator |
Primary outcome
Left ventricular mass (by cardiac MRI)
Time frame: 24 weeks
Left ventricular myocardial triglyceride content (by cardiac MRI)
Time frame: 24 weeks
Left ventricular extracellular volume fraction (by cardiac MRI)
Time frame: 24 weeks
2 secondary outcomes
Systolic blood pressure
Time frame: 24 weeks
Aortic pulse wave velocity (by cardiac MRI)
Time frame: 24 weeks
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 24 Feb 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 400 mg of Magnesium Oxide twice daily for 24 weeks and Open label (none) in people with Obesity, run by Providence VA Medical Center at 1 site in United States.
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 7 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 24 Feb 2023. 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 United States. 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.
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?
Left ventricular mass (by cardiac MRI) (time frame: 24 weeks). The study lists 3 primary outcomes in all. 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 24 Feb 2023.