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

This study has been completed.
Sponsor:
Collaborator:
AlgaeCal Inc.
Information provided by (Responsible Party):
Sprim Italia
ClinicalTrials.gov Identifier:
NCT01609413
First received: May 23, 2012
Last updated: May 31, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Healthy
Dietary Supplement: AlgaeCal
Dietary Supplement: Caltrate 600
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Human Crossover Study to Compare the Bioavailability of Calcium From AlgaeCal® Versus a Proprietary Calcium Dietary Supplement

Resource links provided by NLM:


Further study details as provided by Sprim Italia:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 20
Study Start Date: October 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AlgaeCal
Calcium supplements derived from ocean algae. One dose equals 3 capsules containing 180 mg calcium each.
Dietary Supplement: AlgaeCal
One dose equals 3 times 180 mg of calcium, to be taken one time on the morning of the examination day.
Active Comparator: Caltrate 600
Proprietary calcium supplement. One dose contains 600 mg of calcium.
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.

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.
  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01609413

Locations
Italy
Luigi Sacco Hospital
Milan, Italy, 20157
Sponsors and Collaborators
Sprim Italia
AlgaeCal Inc.
Investigators
Principal Investigator: Emilio Clementi, Prof University of Milan, Milan, Italy
  More Information

No publications provided

Responsible Party: Sprim Italia
ClinicalTrials.gov Identifier: NCT01609413     History of Changes
Obsolete Identifiers: NCT01022593
Other Study ID Numbers: #09-MAX-05-BIO-01b
Study First Received: May 23, 2012
Last Updated: May 31, 2012
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Calcium, Dietary
Calcium Carbonate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014