The COMparison of CALcium Bioavailability Between AlgaeCal® and a Proprietary Supplement (COMCAL)
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ClinicalTrials.gov Identifier: NCT01609413 |
Recruitment Status :
Completed
First Posted : June 1, 2012
Last Update Posted : June 1, 2012
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Tracking Information | ||||
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First Submitted Date ICMJE | May 23, 2012 | |||
First Posted Date ICMJE | June 1, 2012 | |||
Last Update Posted Date | June 1, 2012 | |||
Study Start Date ICMJE | October 2009 | |||
Actual Primary Completion Date | April 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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). [ Time Frame: one day ] 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.
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | The COMparison of CALcium Bioavailability Between AlgaeCal® and a Proprietary Supplement | |||
Official Title ICMJE | A Human Crossover Study to Compare the Bioavailability of Calcium From AlgaeCal® Versus a Proprietary Calcium Dietary Supplement | |||
Brief Summary | 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. |
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Detailed Description | 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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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double (Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
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Condition ICMJE | Healthy | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
20 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | April 2010 | |||
Actual Primary Completion Date | April 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years to 50 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Italy | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01609413 | |||
Other Study ID Numbers ICMJE | #09-MAX-05-BIO-01b | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | SPRIM Advanced Life Sciences, SprimItalia ( Sprim Italia ) | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Sprim Italia | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | AlgaeCal Inc. | |||
Investigators ICMJE |
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PRS Account | SPRIM Advanced Life Sciences, SprimItalia | |||
Verification Date | May 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |