Bioavailability of Magnesium Supplements

NCT03353636 | Completed

• 1 other identifier: TOPN-1501
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Magnesium Deficiency

Outcome Measures

Primary Outcomes (2)

• Serum Magnesium AUC

  serum magnesium area under the concentration time curve

  0-8 hours

• Urinary Magnesium AUC

  urine magnesium area under the concentration time curve

  0-12 hours

Secondary Outcomes (8)

• Serum Magnesium AUC

  0-12 hours

• Urine Magnesium AUC

  0-12 hours

• Urine Magnesium AUC

  0-24 hours

• Serum Magnesium Cmax

  12 hours

• Serum Magnesium Tmax

  12 hours

Study Arms (5)

Natural Calm Magnesium

EXPERIMENTAL

150mg elemental magnesium in a single oral dose

Dietary Supplement: Magnesium

Magnesium Bis-glycinate

ACTIVE COMPARATOR

150mg elemental magnesium in a single oral dose

Dietary Supplement: Magnesium

MAGSmart

ACTIVE COMPARATOR

150mg elemental magnesium in a single oral dose

Dietary Supplement: Magnesium

Magnesium citrate

ACTIVE COMPARATOR

150mg elemental magnesium in a single oral dose

Dietary Supplement: Magnesium

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Magnesium DIETARY_SUPPLEMENT

150mg elemental magnesium

MAGSmart; Magnesium Bis-glycinate; Magnesium citrate; Natural Calm Magnesium

Placebo DIETARY_SUPPLEMENT

Rice flour

Placebo

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Natural Calm Canada: lead
• Nutrasource Pharmaceutical and Nutraceutical Services, Inc.: collaborator

Study Sites (1)

Nutrasource

Guelph, Ontario, N1G 0B4, Canada

Location

MeSH Terms

Conditions

Magnesium Deficiency

Interventions

Magnesium

Condition Hierarchy (Ancestors)

Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Officials

• Anthony Bier, MD

  Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Five period crossover study

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: November 27, 2017
• Study Start: June 27, 2016
• Primary Completion: February 3, 2017
• Study Completion: February 6, 2017
• Last Updated: November 29, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)