ClinicalTrials.gg
CompletedNCT03353636Updated Nov 29, 2017

Bioavailability of Magnesium Supplements

An interventional study of Magnesium and Placebo in Healthy and Magnesium Deficiency, sponsored by Natural Calm Canada. Completed at 1 site in Canada. Open to female participants aged 35 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-29.

Sponsored by Natural Calm Canada · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Jun 2016, registered Nov 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
35 Years to 65 Years
Sex
Female
01

Study summary

The primary objective of this clinical trial is to demonstrate the superiority of Natural Calm magnesium powder with respect to absorption when compared to three marketed forms of magnesium (two magnesium bisglycinate powders and magnesium citrate capsules). The primary endpoints were serum magnesium AUC (0-8h) and urine magnesium AUC (0-8h) after a single dose of 150 mg elemental magnesium.

02

Conditions studied

  • Healthy
  • Magnesium Deficiency

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03

In context

Magnesium Deficiency

24 studies on the registry are indexed under Magnesium Deficiency; 2 are open to participants now.

This study's enrollment of 12 is below the median of 100 across 19 interventional studies indexed under Magnesium Deficiency.

Browse Magnesium Deficiency studies →

Lead sponsor

This is the only study on the registry with Natural Calm Canada as lead sponsor.

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

04

Who can participate

Ages eligible
35 Years to 65 Years
Sexes eligible
Female
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

  • Female 35-65 years of age
  • (greater than 1 year since last menses)
  • Healthy as determined by blood chemistry, hematology, urinalysis and past medical history
  • 18-27.5 kg/m2
  • Normal blood magnesium between 0.65 and 1.05mmol/L
  • Normal urinary 1.18 - 2.18mL/s
  • Non-smoker or ex-smoker for greater than 6 months
  • Agrees to maintain current dietary and physical activity habits for the duration of the study period except as instructed during run-in periods and on test days
  • Willing and able to provide voluntary, written,

Exclusion criteria

Exclusion Criteria:

  • Woman who is peri-menopausal, premenopausal, pregnant, breastfeeding, or planning to become pregnant during the course of the trial
  • Significant cardiac history defined as a history of myocardial infarction (MI); coronary angioplasty or bypass graft(s); valvular disease or repair; unstable angina pectoris; trans ischemic attack (); cerebrovascular accidents (CVA); congestive heart failure; or coronary artery disease (CAD)
  • Uncontrolled hypertension defined as untreated systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg
  • Uncontrolled diabetes defined as fasting blood glucose > 7 mmol/L
  • Treated or untreated thyroid disorders
  • History of renal and/or liver disease
  • History of gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel disease) unresolved gastrointestinal symptoms (e. g. diarrhea, vomiting) or other diseases known to interfere with absorption, distribution, metabolism or excretion of the IP or comparators
  • History of (in previous 5 years), or currently being treated for cancer (excluding basal cell skin carcinoma)
  • Unstable psychiatric disorder
  • Acute illness, as judged by the Investigator, within 2 weeks of the first treatment period (Visit 3a)
  • individuals such as participants that have undergone organ transplantation or participants diagnosed with (HIV)
  • History of hemoglobinopathies such as sickle cell anemia or thalassemia, sideroblastic anemia
  • Significant abnormal liver function as defined as and/or ALT > 2x the (ULN), and/or > 2 x the ULN
  • Serum creatinine > 95 umol/L
  • Anemia of any etiology defined as \< 110 g/L for females
  • Use of anticoagulants, statins, or any other medication for the treatment of hypercholesterolemia and/or hypertension
  • Use of prescribed medication or over the counter supplements for weight loss
  • Use of acute medication, including antacids, within 72 hours of study supplement dose
  • Use of over the counter or prescription products containing magnesium and/or calcium (e.g. multivitamins, calcium carbonate, etc.) within 2 weeks of screening (Visit 1a)
  • Use of medications known to interact or interfere with magnesium absorption (See section 3.8.2)
  • Use of nicotine-containing products in any form (eg, chewing tobacco, gum, patch) within 30 days of the first test period (Visit 3a)
  • Use of caffeine supplements
  • Consumption of more than 50g of chocolate per day
  • Excessive consumption of caffeinated beverages (e.g. >2 cups of any combination of tea, coffee, energy drinks, caffeinated soda, etc. per day) or participants who experience caffeine withdrawal headaches
  • Allergy or sensitivity to study supplement ingredients
  • Food allergies or sensitivities to any of the foods outlined in Appendix 2.
  • Vegan or vegetarian
  • Recent change in weight (up or down more than 10 % of usual body weight, within the past year)
  • Participants who work, evening or night shifts
  • Donation or loss of whole blood prior to the administration of the study product as follows: 50-300 mL of whole blood within 30 days, 301-500 mL of whole blood within 45 days or more than 500 mL within 56 days prior to the administration of the IP or comparators
  • Presence or history (past 6 months) of alcohol or drug abuse; alcohol use of >2 standard alcoholic drinks per day
  • Participant is unwilling or unable to abide by the requirements of the protocol
  • Any condition that would interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study, or put the participant at risk
  • Participant has taken an medicine or has participated in a research study within 30 days prior to the run-in period (Visit 2a)
Terms in these criteria, in plain language(13)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Natural Calm Magnesium

    150mg elemental magnesium in a single oral dose

    Dietary Supplement: Magnesium

  • Active comparator
    Magnesium Bis-glycinate

    150mg elemental magnesium in a single oral dose

    Dietary Supplement: Magnesium

  • Active comparator
    MAGSmart

    150mg elemental magnesium in a single oral dose

    Dietary Supplement: Magnesium

  • Active comparator
    Magnesium citrate

    150mg elemental magnesium in a single oral dose

    Dietary Supplement: Magnesium

  • Placebo comparator
    Placebo

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementMagnesium

    150mg elemental magnesium

  • Dietary supplementPlacebo

    Rice flour

06

What researchers measure

Primary outcomes

  1. Serum Magnesium AUC

    serum magnesium area under the concentration time curve

    Time frame: 0-8 hours

  2. Urinary Magnesium AUC

    urine magnesium area under the concentration time curve

    Time frame: 0-12 hours

Secondary outcomes

  1. Serum Magnesium AUC

    serum magnesium area under the concentration time curve

    Time frame: 0-12 hours

  2. Urine Magnesium AUC

    urine magnesium area under the concentration time curve

    Time frame: 0-12 hours

  3. Urine Magnesium AUC

    urine magnesium area under the concentration time curve

    Time frame: 0-24 hours

  4. Serum Magnesium Cmax

    serum magnesium maximum concentration

    Time frame: 12 hours

  5. Serum Magnesium Tmax

    serum magnesium time of maximum concentration

    Time frame: 12 hours

  6. Urine Magnesium Cmax

    urine magnesium maximum concentration

    Time frame: 24 hours

  7. Urine Magnesium Tmax

    urine magnesium time of maximum concentration

    Time frame: 24 hours

  8. Total urine magnesium

    total amount of magnesium collected in urine over 24h bioavailability period

    Time frame: 24 hours

07

Study locations

1 site
  • Nutrasource
    Guelph, Ontario N1G 0B4, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03353636
Lead sponsor
Natural Calm Canada
Collaborators
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Responsible party
Sponsor
First posted
Nov 27, 2017
Start date
Jun 27, 2016
Primary completion
Feb 3, 2017
Completion
Feb 6, 2017
Last update
Nov 29, 2017

Study contacts

Anthony Bier, MD
principal investigator · Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

Oversight

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

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Magnesium

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