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| Name | Class |
|---|---|
| Nutrasource Pharmaceutical and Nutraceutical Services, Inc. | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Natural Calm Magnesium | Experimental | 150mg elemental magnesium in a single oral dose |
|
| Magnesium Bis-glycinate | Active Comparator | 150mg elemental magnesium in a single oral dose |
|
| MAGSmart | Active Comparator | 150mg elemental magnesium in a single oral dose |
|
| Magnesium citrate | Active Comparator | 150mg elemental magnesium in a single oral dose |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium | Dietary Supplement | 150mg elemental magnesium |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Magnesium AUC | serum magnesium area under the concentration time curve | 0-12 hours |
| Urine Magnesium AUC | urine magnesium area under the concentration time curve |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Bier, MD | Nutrasource Pharmaceutical and Nutraceutical Services, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nutrasource | Guelph | Ontario | N1G 0B4 | Canada |
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| ID | Term |
|---|---|
| D008275 | Magnesium Deficiency |
| ID | Term |
|---|---|
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008274 | Magnesium |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
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Five period crossover study
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| Placebo | Dietary Supplement | Rice flour |
|
| 0-12 hours |
| Urine Magnesium AUC | urine magnesium area under the concentration time curve | 0-24 hours |
| Serum Magnesium Cmax | serum magnesium maximum concentration | 12 hours |
| Serum Magnesium Tmax | serum magnesium time of maximum concentration | 12 hours |
| Urine Magnesium Cmax | urine magnesium maximum concentration | 24 hours |
| Urine Magnesium Tmax | urine magnesium time of maximum concentration | 24 hours |
| Total urine magnesium | total amount of magnesium collected in urine over 24h bioavailability period | 24 hours |
| D008670 |
| Metals |