The COMparison of CALcium Bioavailability Between AlgaeCal® and a Proprietary Supplement (COMCAL)

Tracking Information
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; (submitted: May 31, 2012)	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.
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 Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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.
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: A screening visit to select eligible subjects according to the inclusion/exclusion criteria detailed in the study protocol.; Visit 1 in which subjects who satisfied the selection criteria were assigned to one of the two intervention sequences (Algaecal®/ LCCS or LCCS/Algaecal®) according to the randomization list;; Visit 2, after at least one week of wash-out in respect to visit 1. Subjects arrived at the centre early in the morning The first blood sample was drawn before the ingestion of the calcium supplement and every hour after for the following 8 hours. Urine sample were collected before the ingestion of the calcium supplement and every 2 hours after for the following 8 hours. During each study visit the subjects were present in the site centre from the morning to the evening. Calcium supplement was given under fasted condition and during the eight hours after the product ingestion, according to the protocol, only water ad libitum was allowed.
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Basic Science
Condition ICMJE	Healthy
Intervention ICMJE	Dietary Supplement: AlgaeCal One dose equals 3 times 180 mg of calcium, to be taken one time on the morning of the examination day.; Dietary Supplement: Caltrate 600 One dose equals 1 capsule of 600 mg calcium, to be taken one time on the morning of the examination day.
Study Arms	Experimental: AlgaeCal Calcium supplements derived from ocean algae. One dose equals 3 capsules containing 180 mg calcium each. Intervention: Dietary Supplement: AlgaeCal; Active Comparator: Caltrate 600 Proprietary calcium supplement. One dose contains 600 mg of calcium. Intervention: Dietary Supplement: Caltrate 600
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: May 31, 2012)	20
Original Actual Enrollment ICMJE	Same as current
Actual Study Completion Date	April 2010
Actual Primary Completion Date	April 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Healthy free-living men aged 20 to 50 years-old; Consent to the study and compliance with study product Exclusion Criteria: Calcium supplements or calcitriol taken one week or less before the first kinetic visit; Heart disease; Circulation problems; Parathyroid gland disorder; Kidney disease; Past or present kidney stones; Gastrointestinal disturbances that could potentially affect the absorption of calcium supplements
Sex/Gender	Sexes Eligible for Study: Male
Ages	20 Years to 50 Years (Adult)
Accepts Healthy Volunteers	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	Not Provided
Responsible Party	SPRIM Advanced Life Sciences, SprimItalia ( Sprim Advanced Life Sciences )
Study Sponsor ICMJE	Sprim Advanced Life Sciences
Collaborators ICMJE	AlgaeCal Inc.
Investigators ICMJE	Principal Investigator: Emilio Clementi, Prof University of Milan, Milan, Italy
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