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

• ClinicalTrials.gov Identifier: NCT01609413
• Recruitment Status: Completed
• First Posted: June 1, 2012
• Last Update Posted: June 1, 2012
• Sponsor: Sprim Advanced Life Sciences
• Collaborator: AlgaeCal Inc.
• Information provided by (Responsible Party): SPRIM Advanced Life Sciences, SprimItalia ( Sprim Advanced Life Sciences )

Tracking Information

• First Submitted Date: May 23, 2012
• First Posted Date: June 1, 2012
• Last Update Posted Date: June 1, 2012
• Study Start Date: October 2009
• Actual Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The COMparison of CALcium Bioavailability Between AlgaeCal® and a Proprietary Supplement
• Official Title: 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:

1. A screening visit to select eligible subjects according to the inclusion/exclusion criteria detailed in the study protocol.
2. 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;
3. 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Basic Science
• Condition: Healthy

Intervention

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 31, 2012): 20
• Original Actual Enrollment: 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

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: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT01609413
• Other Study ID Numbers: #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: Sprim Advanced Life Sciences
• Collaborators: AlgaeCal Inc.

Investigators

• Principal Investigator: Emilio Clementi, Prof; University of Milan, Milan, Italy

• PRS Account: SPRIM Advanced Life Sciences, SprimItalia
• Verification Date: May 2012