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History of Changes for Study: NCT01609413
The COMparison of CALcium Bioavailability Between AlgaeCalĀ® and a Proprietary Supplement (COMCAL)
Latest version (submitted May 31, 2012) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 31, 2012 None (earliest Version on record)
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Study NCT01609413
Submitted Date:  May 31, 2012 (v1)

Open or close this module Study Identification
Unique Protocol ID: #09-MAX-05-BIO-01b
Brief Title: The COMparison of CALcium Bioavailability Between AlgaeCal® and a Proprietary Supplement (COMCAL)
Official Title: A Human Crossover Study to Compare the Bioavailability of Calcium From AlgaeCal® Versus a Proprietary Calcium Dietary Supplement
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2012
Overall Status: Completed
Study Start: October 2009
Primary Completion: April 2010 [Actual]
Study Completion: April 2010 [Actual]
First Submitted: May 23, 2012
First Submitted that
Met QC Criteria:
May 31, 2012
First Posted: June 1, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:
May 31, 2012
Last Update Posted: June 1, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Sprim Italia
Responsible Party: Sponsor
Collaborators: AlgaeCal Inc.
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Healthy
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Basic Science
Study Phase: Phase 1
Interventional Study Model: Crossover Assignment
Number of Arms: 2
Masking: Double (Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 20 [Actual]
Open or close this module Arms and Interventions
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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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.
Open or close this module Eligibility
Minimum Age: 20 Years
Maximum Age: 50 Years
Sex: Male
Gender Based:
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
Open or close this module Contacts/Locations
Study Officials: Emilio Clementi, Prof
Principal Investigator
University of Milan, Milan, Italy
Locations: Italy
Luigi Sacco Hospital
Milan, Italy, 20157
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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