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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01609413
Recruitment Status : Completed
First Posted : June 1, 2012
Last Update Posted : June 1, 2012
Sponsor:
Collaborator:
AlgaeCal Inc.
Information provided by (Responsible Party):
SPRIM Advanced Life Sciences, SprimItalia ( Sprim Advanced Life Sciences )

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 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.

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  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
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  ICMJE
  • 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  ICMJE 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  ICMJE
Sexes Eligible for Study: Male
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
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