Biocomparison Study (NCT01638182) | Clinical Trial Compass
CompletedNot Applicable
Biocomparison Study
Netherlands81 participantsStarted 2011-03
Plain-language summary
The effects of two vitamin K-forms on carboxylation of the vitamin K-dependent proteins osteocalcin and matrix-gla protein will be compared after supplementing these vitamins in a nutritional dose range.
The investigators hypothesized that MK-7 is more effective than K1 at a dose comparable to the RDA of vitamin K.
Who can participate
Age range20 Years – 80 Years
SexALL
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Inclusion Criteria:
* Healthy men and women, aged between 20-80 years
* Normal body weight and height (18.5 kg/m2 \< BMI \< 30 kg/m2)
* Stable body weight (weight gain or loss \< 3 kg in past 3 mo)
* Written consent to take part in the study
* Agreement to adhere to dietary restrictions required by the protocol
Exclusion Criteria:
* Abuse of drugs and/or alcohol
* Use of vitamin supplements containing vitamin K
* Pregnancy
* (a history of) metabolic or gastrointestinal diseases, e.g. hepatic or renal disorders, osteoporosis
* Chronic degenerative and/or inflammatory diseases, e.g. diabetes mellitus, cancer, cardiovascular disease
* Use of oral anticoagulants, drugs or hormones that influence bone metabolism
* Corticoid treatment
* Subjects with anaemia or subjects who recently donated blood or plasma
* Systemic treatment or topical treatment likely to interfere with coagulation metabolism (salicylates, antibiotics)