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Bioavailability of Magnesium Supplements

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ClinicalTrials.gov Identifier: NCT03353636
Recruitment Status : Completed
First Posted : November 27, 2017
Last Update Posted : November 29, 2017
Sponsor:
Collaborator:
Nutrasource Diagnostics Inc.
Information provided by (Responsible Party):
Natural Calm Canada

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Magnesium Deficiency Dietary Supplement: Magnesium Dietary Supplement: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Five period crossover study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
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
Actual Study Start Date : June 27, 2016
Actual Primary Completion Date : February 3, 2017
Actual Study Completion Date : February 6, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Magnesium

Arm Intervention/treatment
Experimental: Natural Calm Magnesium
150mg elemental magnesium in a single oral dose
Dietary Supplement: Magnesium
150mg elemental magnesium

Active Comparator: Magnesium Bis-glycinate
150mg elemental magnesium in a single oral dose
Dietary Supplement: Magnesium
150mg elemental magnesium

Active Comparator: MAGSmart
150mg elemental magnesium in a single oral dose
Dietary Supplement: Magnesium
150mg elemental magnesium

Active Comparator: Magnesium citrate
150mg elemental magnesium in a single oral dose
Dietary Supplement: Magnesium
150mg elemental magnesium

Placebo Comparator: Placebo Dietary Supplement: Placebo
Rice flour




Primary Outcome Measures :
  1. Serum Magnesium AUC [ Time Frame: 0-8 hours ]
    serum magnesium area under the concentration time curve

  2. Urinary Magnesium AUC [ Time Frame: 0-12 hours ]
    urine magnesium area under the concentration time curve


Secondary Outcome Measures :
  1. Serum Magnesium AUC [ Time Frame: 0-12 hours ]
    serum magnesium area under the concentration time curve

  2. Urine Magnesium AUC [ Time Frame: 0-12 hours ]
    urine magnesium area under the concentration time curve

  3. Urine Magnesium AUC [ Time Frame: 0-24 hours ]
    urine magnesium area under the concentration time curve

  4. Serum Magnesium Cmax [ Time Frame: 12 hours ]
    serum magnesium maximum concentration

  5. Serum Magnesium Tmax [ Time Frame: 12 hours ]
    serum magnesium time of maximum concentration

  6. Urine Magnesium Cmax [ Time Frame: 24 hours ]
    urine magnesium maximum concentration

  7. Urine Magnesium Tmax [ Time Frame: 24 hours ]
    urine magnesium time of maximum concentration

  8. Total urine magnesium [ Time Frame: 24 hours ]
    total amount of magnesium collected in urine over 24h bioavailability period



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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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
  • 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

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 (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
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03353636


Locations
Canada, Ontario
Nutrasource
Guelph, Ontario, Canada, N1G 0B4
Sponsors and Collaborators
Natural Calm Canada
Nutrasource Diagnostics Inc.
Investigators
Principal Investigator: Anthony Bier, MD Nutrasource Diagnostics Inc.

Responsible Party: Natural Calm Canada
ClinicalTrials.gov Identifier: NCT03353636     History of Changes
Other Study ID Numbers: TOPN-1501
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Magnesium Deficiency
Deficiency Diseases
Malnutrition
Nutrition Disorders