Bioequivalence Clinical Trial
Official title:
Comparison of Bioavailability of Three Different Vitamin K2 Formulations
The primary objective of this study is to compare absorption of vitamin K2 (menaquinone-7) after intake of three different vitamin K2 supplements.
Status | Completed |
Enrollment | 24 |
Est. completion date | August 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 20 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Healthy men and women, aged between 20 and 40 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 - Soy allergy - Pregnancy - a history of) metabolic or gastrointestinal diseases including hepatic disorders - Chronic degenerative and/or inflammatory diseases, e.g. diabetes mellitus, renal failure - Use of oral anticoagulants - 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) |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | VitaK BV / Maastricht University Medical Center | Maastricht |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MK-7 absorption profiles | The purpose of this study is to compare the MK-7 absorption profiles after intake of three different vitamin K2 (MK-7) products that are already on the market. The main study parameter is therefore the calculated AUC value from the individual MK-7 absorption profiles. | 9 weeks | No |
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