Biocomparison Study
Comparison of Effects of Nutritional Doses Vitamin K1 and K2 on Carboxylation
1 other identifier
interventional
81
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 9, 2012
CompletedFirst Posted
Study publicly available on registry
July 11, 2012
CompletedJuly 11, 2012
July 1, 2012
3 months
July 9, 2012
July 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
carboxylation of osteocalcin
The primary objective of the study is to compare the effects of K1 and MK-7 on circulating ucOC levels after supplementing these vitamins at a nutritional dose.
12 weeks
Secondary Outcomes (1)
carboxylation of matrix-gla protein
12 weeks
Study Arms (3)
vitamin K1 capsules
ACTIVE COMPARATOR27 participants received for three months 1 vitamin K1-capsule per day containing 52 µg of K1
Vitamin K2-capsules
ACTIVE COMPARATOR27 participants received for three months 1 vitamin K2-capsule per day containing 75 µg of MK-7.
Placebo capsules
PLACEBO COMPARATOR27 participants received for 3 months 1 placebo capsule per day
Interventions
27 participants received for three months 1 placebo capsule per day
27 participants received for 3 months 1 vitamin K1-capsule per day containing 52 µg of K1/day
27 participants received for 3 months 1 vitamin K2-capsule per day containing 75 µg of MK-7.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VitaK BV / Maastricht University Medicial Center
Maastricht, Netherlands
Study Officials
- PRINCIPAL INVESTIGATOR
Cees Vermeer, PhD
VitaK BV Maastricht University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2012
First Posted
July 11, 2012
Study Start
March 1, 2011
Primary Completion
June 1, 2011
Study Completion
September 1, 2011
Last Updated
July 11, 2012
Record last verified: 2012-07