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| Name | Class |
|---|---|
| AlgaeCal Inc. | INDUSTRY |
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In a crossover, single blind, randomized trial the calcium bioavailability of two calcium supplements will be compared.That is AlgaeCal®(Algaecal Inc, Vancouver, Canada)(1 dose is 3 capsules of 180 mg calcium), derived from ocean algae and the proprietary calcium supplement Caltrate 600® (Wyeth Consumer Healthcare, Inc).
After a screening visits 20 healthy male subjects aged 20-50 years will spend a day at the research center to examine calcium bioavailability data. They will be randomized to consume either first the AlgaeCal® supplement or the Caltrate 600® supplement. After a one week wash-out period subjects will be supplemented with the other supplement. During the examination day blood and urine samples will be collected before and until eight hours after the supplementation for analyses of calcium, creatinine, phosphorus, albumin and 25 Hydroxy vitamin D. Subjects are instructed to avoid taking calcium and/or vitamin D supplements 1 week before and during the entire study period. In addition, they are not allowed to take medication that may affect calcium metabolism.
The hypothesis of the study is that calcium bioavailability of the AlgaeCal® supplement will be higher than that of the Caltrate 600® supplement.
This was a single centre, single-dose, randomized, two way cross-over study in healthy male subjects.
The study consisted of the following visits:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AlgaeCal | Experimental | Calcium supplements derived from ocean algae. One dose equals 3 capsules containing 180 mg calcium each. |
|
| Caltrate 600 | Active Comparator | Proprietary calcium supplement. One dose contains 600 mg of calcium. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AlgaeCal | Dietary Supplement | One dose equals 3 times 180 mg of calcium, to be taken one time on the morning of the examination day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Will be measured the oral bioavailability of calcium from a single dose of AlgaeCal® (Algaecal, Vancouver, Canada) compared to a proprietary calcium supplement (Caltrate 600®, Whyett Consumer healthcare, Inc). | During the examination day blood and urine samples will be collected before and untill eight hours after the supplementation for analyses of calcium, creatinine, phosphorus, albumin and 25 Hydroxy vitamin D. | one day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emilio Clementi, Prof | University of Milan, Milan, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Luigi Sacco Hospital | Milan | Milan | 20157 | Italy |
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| ID | Term |
|---|---|
| D002119 | Calcium Carbonate |
| ID | Term |
|---|---|
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
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| Caltrate 600 | Dietary Supplement | One dose equals 1 capsule of 600 mg calcium, to be taken one time on the morning of the examination day. |
|
| D017554 |
| Carbon Compounds, Inorganic |
| D008903 | Minerals |