The COMparison of CALcium Bioavailability Between AlgaeCal® and a Proprietary Supplement
Condition: Healthy
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): AlgaeCal; Caltrate 600
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): One dose equals 3 times 180 mg of calcium, to be taken one time on the morning of the examination day.; One dose equals 1 capsule of 600 mg calcium, to be taken one time on the morning of the examination day.
Intervention MeSH terms: Calcium Carbonate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science