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Biocomparison Study

NCT ID: NCT01638182

Last Updated: 2012-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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Vitamin K is a group name for the naturally occurring phylloquinone (K1) and menaquinones (MK-n; K2). The latter can be subdivided into the short-chain (e.g. MK-4) and the long-chain (e.g. MK-7, MK-8, and MK-9) menaquinones. Earlier studies have shown that high vitamin K intake leads to improved bone and vascular health by increased carboxylation of vitamin K-dependent proteins in these tissues. In the dietary range, MK-7 has been suggested to be the most effective cofactor for the carboxylation of Gla-proteins, such as osteocalcin (OC) and matrix-Gla protein (MGP).Until now, no randomized controlled trial has compared the efficacy of K1 versus MK-7 in a nutritional dose range. The investigators are therefore interested to compare the effects of K1 and MK-7 on OC and MGP carboxylation after supplementing these vitamins at a dose not exceeding the RDA.

Conditions

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Bone Health Vascular Health

Keywords

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phylloquinone, menaquinone-7 vitamin K-status efficacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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vitamin K1 capsules

27 participants received for three months 1 vitamin K1-capsule per day containing 52 µg of K1

Group Type ACTIVE_COMPARATOR

Vitamin K1-capsules

Intervention Type DIETARY_SUPPLEMENT

27 participants received for 3 months 1 vitamin K1-capsule per day containing 52 µg of K1/day

Vitamin K2-capsules

27 participants received for three months 1 vitamin K2-capsule per day containing 75 µg of MK-7.

Group Type ACTIVE_COMPARATOR

Vitamin K2-capsules

Intervention Type DIETARY_SUPPLEMENT

27 participants received for 3 months 1 vitamin K2-capsule per day containing 75 µg of MK-7.

Placebo capsules

27 participants received for 3 months 1 placebo capsule per day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

27 participants received for three months 1 placebo capsule per day

Interventions

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Placebo

27 participants received for three months 1 placebo capsule per day

Intervention Type DIETARY_SUPPLEMENT

Vitamin K1-capsules

27 participants received for 3 months 1 vitamin K1-capsule per day containing 52 µg of K1/day

Intervention Type DIETARY_SUPPLEMENT

Vitamin K2-capsules

27 participants received for 3 months 1 vitamin K2-capsule per day containing 75 µg of MK-7.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cees Vermeer, PhD

Role: PRINCIPAL_INVESTIGATOR

VitaK BV Maastricht University

Locations

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VitaK BV / Maastricht University Medicial Center

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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10-3-018

Identifier Type: -

Identifier Source: org_study_id