HealthyNCT03353636
Bioavailability of Magnesium Supplements
A study testing Magnesium in people with Healthy and Magnesium Deficiency, run by Natural Calm Canada at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 35 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Magnesium Deficiency
- What is being tested?
- Magnesium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 27 Jun 2016to 6 Feb 2017
- 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 35 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female 35-65 years of age
- Post-menopausal (greater than 1 year since last menses)
- Healthy as determined by blood chemistry, hematology, urinalysis and past medical history
- BMI 18-27.5 kg/m2
- Normal blood magnesium between 0.65 and 1.05mmol/L
- Normal urinary creatinine clearance 1.18 - 2.18mL/s
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- 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, informed consent
Who cannot join
- 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 (TIA); 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
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- History of clinically significant 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)
- Immunocompromised individuals such as participants that have undergone organ transplantation or participants diagnosed with human immunodeficiency virus (HIV)
- History of hemoglobinopathies such as sickle cell anemia or thalassemia, sideroblastic anemia
- Significant abnormal liver function as defined as AST and/or ALT > 2x the upper limit of normal (ULN), and/or bilirubin > 2 x the ULN
- Serum creatinine > 95 umol/L
- Anemia of any etiology defined as hemoglobin < 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 investigational medicine or has participated in a research study within 30 days prior to the run-in period (Visit 2a)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Crossover Trial to Compare the Bioavailability of Magnesium From Magnesium Carbonate Powder With Three Marketed Magnesium Supplements
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.
- Conditions
- Healthy, Magnesium Deficiency
- Being tested
- Magnesium, Placebo
- Medical subject headings
- Magnesium Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnesiumDietary supplement
150mg elemental magnesium
PlaceboDietary supplement
Rice flour
| Study group | Role | What they receive |
|---|---|---|
| Natural Calm Magnesium | Experimental | 150mg elemental magnesium in a single oral dose Receives: Dietary Supplement: Magnesium |
| Magnesium Bis-glycinate | Active comparator | 150mg elemental magnesium in a single oral dose Receives: Dietary Supplement: Magnesium |
| MAGSmart | Active comparator | 150mg elemental magnesium in a single oral dose Receives: Dietary Supplement: Magnesium |
| Magnesium citrate | Active comparator | 150mg elemental magnesium in a single oral dose Receives: Dietary Supplement: Magnesium |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Magnesium AUC
serum magnesium area under the concentration time curve
Measured: 0-8 hours
Urinary Magnesium AUC
urine magnesium area under the concentration time curve
Measured: 0-12 hours
Secondary outcomes (8)
Serum Magnesium AUC
serum magnesium area under the concentration time curve
Measured: 0-12 hours
Urine Magnesium AUC
urine magnesium area under the concentration time curve
Measured: 0-12 hours
Urine Magnesium AUC
urine magnesium area under the concentration time curve
Measured: 0-24 hours
Serum Magnesium Cmax
serum magnesium maximum concentration
Measured: 12 hours
Serum Magnesium Tmax
serum magnesium time of maximum concentration
Measured: 12 hours
Urine Magnesium Cmax
urine magnesium maximum concentration
Measured: 24 hours
Urine Magnesium Tmax
urine magnesium time of maximum concentration
Measured: 24 hours
Total urine magnesium
total amount of magnesium collected in urine over 24h bioavailability period
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start27 Jun 2016
- Primary completion3 Feb 2017
- Study completion6 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Five period crossover study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natural Calm Canada
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Responsible party
- Sponsor
- Investigators
- Anthony Bier, MD, Principal investigator, Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353636
- Sponsor's protocol ID
- TOPN-1501
- Status last verified
- Nov 2017
- First submitted
- 21 Nov 2017
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Crossover Trial to Compare the Bioavailability of Magnesium From Magnesium Carbonate Powder With Three Marketed Magnesium Supplements
- ClinicalTrials.gov ID
- NCT03353636
- Acronym / sponsor ID
- TOPN-1501
- Conditions
- Healthy, Magnesium Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Natural Calm CanadaIndustry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Study start
- 27 Jun 2016 (actual)
- Primary completion
- 3 Feb 2017 (actual)
- Study completion
- 6 Feb 2017 (actual)
- First posted
- 27 Nov 2017 (actual)
- 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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Five period crossover study
| Arm | Type | Receives |
|---|---|---|
| Natural Calm Magnesium | Experimental | Dietary Supplement: Magnesium150mg elemental magnesium in a single oral dose |
| Magnesium Bis-glycinate | Active comparator | Dietary Supplement: Magnesium150mg elemental magnesium in a single oral dose |
| MAGSmart | Active comparator | Dietary Supplement: Magnesium150mg elemental magnesium in a single oral dose |
| Magnesium citrate | Active comparator | Dietary Supplement: Magnesium150mg elemental magnesium in a single oral dose |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female 35-65 years of age
- Post-menopausal (greater than 1 year since last menses)
- Healthy as determined by blood chemistry, hematology, urinalysis and past medical history
- BMI 18-27.5 kg/m2
- Normal blood magnesium between 0.65 and 1.05mmol/L
Key exclusion criteria (34 listed)
- 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 (TIA); 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
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 |
|---|---|---|
| Magnesium150mg elemental magnesium | Dietary supplement | MAGSmart, Magnesium Bis-glycinate, Magnesium citrate, Natural Calm Magnesium |
| PlaceboRice flour | Dietary supplement | Placebo |
Primary outcome
Serum Magnesium AUC
Time frame: 0-8 hours
serum magnesium area under the concentration time curve
Urinary Magnesium AUC
Time frame: 0-12 hours
urine magnesium area under the concentration time curve
8 secondary outcomes
Serum Magnesium AUC
Time frame: 0-12 hours
Urine Magnesium AUC
Time frame: 0-12 hours
Urine Magnesium AUC
Time frame: 0-24 hours
Serum Magnesium Cmax
Time frame: 12 hours
Serum Magnesium Tmax
Time frame: 12 hours
Urine Magnesium Cmax
Time frame: 24 hours
Urine Magnesium Tmax
Time frame: 24 hours
Total urine magnesium
Time frame: 24 hours
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 29 Nov 2017.
- Individual participant dataSharing planned: No
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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.
Anthony Bier, MD principal investigator
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium in people with Healthy and Magnesium Deficiency, run by Natural Calm Canada at 1 site in Canada.
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 9 inclusion and 34 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 29 Nov 2017. 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 Canada. 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.
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?
Serum Magnesium AUC (time frame: 0-8 hours). The study lists 2 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 29 Nov 2017.