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

NCT01609413 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2012-06-01

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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.

Sponsors & Collaborators

  • AlgaeCal Inc.

    collaborator INDUSTRY

  • Sprim Italia

    lead UNKNOWN

Principal Investigators

  • Emilio Clementi, Prof · University of Milan, Milan, Italy

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01609413 on ClinicalTrials.gov