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Status unknownNCT03632590Updated Aug 15, 2018

Magnesium and Vascular Stiffness

An interventional study of Magnesium Citrate and Magnesium Sulfate in Vascular Stiffness and Blood Pressure, sponsored by University Medical Center Groningen. Status unknown at 1 site in Netherlands. Open to participants aged 45 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-15.

Sponsored by University Medical Center Groningen · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Aug 2018), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Mar 2018, registered Aug 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
162
Allocation
Randomized
Ages
45 Years to 75 Years
Sex
All
01

Study summary

This four-arm randomized controlled trial was designed to study the effects of magnesium supplements (total daily dose: 450 mg elemental magnesium) on vascular stiffness in healthy overweight and slightly obese men and women. In addition, the effects of magnesium supplements on blood pressure and gut microbiota will be evaluated. Three groups will receive magnesium supplements (magnesium oxide, magnesium citrate or magnesium sulphate) and one group will receive a placebo.

Read the detailed description

Observational epidemiologic studies have observed an inverse relationship between daily dietary magnesium intake and blood pressure. Except for blood pressure, magnesium may also beneficially affect other cardiovascular risk markers. Whether all these effects translate into improved vascular function is not known. Different vascular function markers at various stages on the pathway between diet and disease exist. One of these markers, vascular stiffness, is closely related to the process of atherosclerosis, an independent cardiovascular risk factor, and predictive of future cardiovascular events and mortality. A recently published intervention study showed that oral magnesium citrate supplementation of 350 mg per day for 24 weeks was well-tolerated and improved vascular stiffness by 1.0 m/s. Importantly, it was not established whether the beneficial effect on vascular stiffness was due to the supplementation of magnesium or due to citrate. This may involve effects on gut microbiota and systemic metabolic effects. The current study was designed to (1) reproduce the result of the earlier study and to (2) investigate whether there is a difference between different commonly used magnesium salts (magnesium citrate, magnesium sulphate and magnesium oxide) in terms of effects on vascular stiffness, blood pressure and gut microbiota.

02

Conditions studied

  • Vascular Stiffness
  • Blood Pressure

Keywords

  • Magnesium
  • Supplements
03

In context

Lead sponsor

University Medical Center Groningen is the lead sponsor of 625 studies on the registry; 174 are open to participants now.

Browse University Medical Center Groningen studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged between 45-70 years
  • Women postmenopausal: two or more years after last menstruation
  • BMI between 25-35 kg/m2 (overweight and slightly obese)
  • Plasma glucose \< 7.0 mmol/L
  • Serum total cholesterol \< 8.0 mmol/L (further testing is recommended for excessive hyperlipidemia (serum total cholesterol ≥ 8.0 mmol/L) according to the Standard for cardiovascular risk management of the Dutch general practitioners community (NHG))
  • Serum triacylglycerol \< 4.5 mmol/L (Friedewald formula)
  • No current smoker
  • No diabetic patients
  • No familial hypercholesterolemia
  • No abuse of drugs
  • Less than 21 alcoholic consumptions per week
  • Stable body weight (weight gain or loss \<3 kg in the past three months)
  • No use of proton pump inhibitors
  • No use of magnesium supplements
  • No severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis
  • No active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebro vascular accident
  • Willingness to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study and during the study
  • No difficult venipuncture as evidenced during the screening visit
  • Written informed consent

Exclusion criteria

Exclusion Criteria:

  • High habitual dietary magnesium intake (defined as urinary magnesium excretion of 7.0 or 5.9 mmol/24-h or more for men and women, respectively)
  • Plasma glucose ≥ 7.0 mmol/L
  • Serum total cholesterol ≥ 8.0 mmol/L
  • Serum triacylglycerol ≥ 4.5 mmol/L
  • Current smoker, or smoking cessation \<12 months
  • Diabetic patients
  • Familial hypercholesterolemia
  • Abuse of drugs
  • More than 21 alcoholic consumptions per week
  • Unstable body weight (weight gain or loss > 3 kg in the past three months)
  • Use of proton pump inhibitors
  • Use of magnesium supplements
  • Severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis
  • Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebro vascular accident
  • Not willing to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study and during the study
  • Not or difficult to venipuncture as evidenced during the screening visit
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
162 participants (estimated)

Study arms

  • Experimental
    Magnesium Citrate

    450 mg of Magnesium Citrate per day

    Dietary Supplement: Magnesium Citrate

  • Experimental
    Magnesium Sulfate

    450 mg of Magnesium Sulfate per day

    Dietary Supplement: Magnesium Sulfate

  • Experimental
    Magnesium Oxide

    450 mg of Magnesium Oxide per day

    Dietary Supplement: Magnesium Oxide

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • Dietary supplementMagnesium Citrate

    450 mg of Magnesium Citrate per day (6 capsules per day) for 24 weeks

  • Dietary supplementMagnesium Sulfate

    450 mg of Magnesium Sulfate per day (6 capsules per day) for 24 weeks

  • Dietary supplementMagnesium Oxide

    450 mg of Magnesium Oxide per day (6 capsules per day) for 24 weeks

  • DrugPlacebo

    The placebo capsules will contain starch (Amylum solani) for 24 weeks

06

What researchers measure

Primary outcomes

  1. Change in vascular stiffness

    Measured from carotid-femoral pulse wave velocity (PWV). For this assessment, a SphygmoCor will be used (SphygmoCor v9, AtCor Medical).

    Time frame: Baseline, FU-1 (2 weeks), FU-2 (12 weeks), and FU-3 (24 weeks)

Secondary outcomes

  1. Change in blood pressure

    Measured from a semi continuous blood pressure monitoring device

    Time frame: Baseline, FU-1 (2 weeks), FU-2 (12 weeks), and FU-3 (24 weeks)

  2. Change in gut microbiota

    Measured from fecal samples

    Time frame: Baseline, FU-1 (2 weeks), FU-2 (12 weeks), and FU-3 (24 weeks)

07

Study locations

1 of 1 sites recruiting
  • University Medical Center Groningen
    Groningen, 9713 GZ, Netherlands
    Recruiting
08

References and documents

Publications

  • Schutten JC, Joris PJ, Groendijk I, Eelderink C, Groothof D, van der Veen Y, Westerhuis R, Goorman F, Danel RM, de Borst MH, Bakker SJL. Effects of Magnesium Citrate, Magnesium Oxide, and Magnesium Sulfate Supplementation on Arterial Stiffness: A Randomized, Double-Blind, Placebo-Controlled Intervention Trial. J Am Heart Assoc. 2022 Mar 15;11(6):e021783. doi: 10.1161/JAHA.121.021783. Epub 2022 Mar 5. PubMed 35253448 ↗
  • Schutten JC, Joris PJ, Mensink RP, Danel RM, Goorman F, Heiner-Fokkema MR, Weersma RK, Keyzer CA, de Borst MH, Bakker SJL. Effects of magnesium citrate, magnesium oxide and magnesium sulfate supplementation on arterial stiffness in healthy overweight individuals: a study protocol for a randomized controlled trial. Trials. 2019 May 28;20(1):295. doi: 10.1186/s13063-019-3414-4. PubMed 31138315 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2018 (actual). Primary completion is estimated for Jan 2020, 22 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 6, 2018
First posted
Aug 15, 2018
StartActual
Mar 27, 2018
Primary completionEst.
Jan 2020
CompletionEst.
Jan 2020
Last update
Aug 15, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 15, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03632590
Lead sponsor
University Medical Center Groningen
Collaborators
Nedmag Industries Mining and Manufacturing B.V.
Responsible party
Stephan J.L. Bakker (Prof. dr., University Medical Center Groningen) — Principal investigator
First posted
Aug 15, 2018
Start date
Mar 27, 2018
Primary completion
Jan 2020 (estimated)
Completion
Jan 2020 (estimated)
Last update
Aug 15, 2018

Study contacts

Joëlle C Schutten, MSc
Contact
j.c.schutten@umcg.nl
+31 50 3612679
Stephan JL Bakker, MD-PhD
principal investigator · University Medical Center Groningen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Magnesium citrate · Magnesium Sulfate · Magnesium Oxide

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