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