CClinicalTrials.gg
CompletedNCT00732576Updated Feb 24, 2017

Effects of Omega-3 Fatty Acids and Menaquinone-7 on Thrombotic Tendency

An interventional study of menaquinone-7 and fish oil in Atherosclerosis, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 25 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-24.

Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
57
Allocation
Randomized
Ages
25 Years to 50 Years
Sex
All
01

Study summary

Omega-3 fatty acids are notably present in fish oil and krill oil, and are known to have beneficial effects on the vasculature. Vitamin K2 is known for preventing vascular calcification. In this study we investigate a potential synergy between the effects of either fish or krill oil and menaquinone-7, which is one of K2 vitamins.

02

Conditions studied

  • Atherosclerosis

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Keywords

  • Cardiovascular
  • Calcification
03

In context

Atherosclerosis

1,567 studies on the registry are indexed under Atherosclerosis; 264 are open to participants now.

This study's enrollment of 57 is below the median of 106 across 882 interventional studies indexed under Atherosclerosis.

Browse Atherosclerosis studies →

Lead sponsor

Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy subjects - BMI \< 30
  • written informed consent

Exclusion criteria

Exclusion Criteria:

  • Use of oral anticoagulants
  • Coagulation disorders
  • Use of multivitamin supplements
  • Use of corticosteroids, anticonceptives
  • hypertriglyceridemia, hypercholesterolemia
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
57 participants (actual)

Study arms

  • Active comparator
    1

    9 fish oil capsules, equivalent to 3 gram per day of n-3 polyunsaturated fatty acids (PUFA)

    Dietary Supplement: fish oil

  • Active comparator
    2

    9 fish oil capsules, equivalent to 3 gram per day of n-3 polyunsaturated fatty acids (PUFA) including 1 capsule of menaquinone-7 per day (10 µg)

    Dietary Supplement: menaquinone-7 · Dietary Supplement: fish oil

  • Active comparator
    3

    9 fish oil capsules, equivalent to 3 gram per day of n-3 polyunsaturated fatty acids (PUFA) including 2 capsules of menaquinone-7 per day (20 µg per day)

    Dietary Supplement: menaquinone-7 · Dietary Supplement: fish oil

  • Active comparator
    4

    9 fish oil capsules, equivalent to 3 gram per day of n-3 polyunsaturated fatty acids (PUFA) including 1 capsule of menaquinone-7 per day (45 µg per day)

    Dietary Supplement: menaquinone-7 · Dietary Supplement: fish oil

  • Active comparator
    5

    9 krill oil capsules, equivalent to 1,5 gram per day of n-3 polyunsaturated fatty acids (PUFA)

    Dietary Supplement: krill oil

  • Active comparator
    6

    9 krill oil capsules, equivalent to 1,5 gram per day of n-3 polyunsaturated fatty acids (PUFA) including 1 capsule of menaquinone-7 per day (10 µg)

    Dietary Supplement: menaquinone-7 · Dietary Supplement: krill oil

  • Active comparator
    7

    9 krill oil capsules, equivalent to 1,5 gram per day of n-3 polyunsaturated fatty acids (PUFA) including 2 capsules of menaquinone-7 per day (20 µg per day)

    Dietary Supplement: menaquinone-7 · Dietary Supplement: krill oil

  • Active comparator
    8

    9 krill oil capsules, equivalent to 1,5 gram per day of n-3 polyunsaturated fatty acids (PUFA) including 1 capsule of menaquinone-7 per day (45 µg per day)

    Dietary Supplement: menaquinone-7 · Dietary Supplement: krill oil

Interventions

  • Dietary supplementmenaquinone-7

    capsule consisting of 10, 20 or 45 µg menaquinone-7 per day during 8 weeks

    Also known as: MenaQ7

  • Dietary supplementfish oil

    9 fish oil capsules equivalent to 3 gram per day of n-3 polyunsaturated fatty acids during 12 weeks

  • Dietary supplementkrill oil

    9 krill oil capsules, equivalent to 1,5 gram per day of n-3 polyunsaturated fatty acids (PUFA) during 12 weeks

06

What researchers measure

Primary outcomes

  1. Endogenous Thrombin Potential (ETP)

    Time frame: 12 weeks

Secondary outcomes

  1. Osteocalcin carboxylation

    Time frame: 12 weeks

  2. Matrix Gla-protein carboxylation

    Time frame: 12 weeks

07

Study locations

1 site
  • VitaK - Maastricht University
    Maastricht, 6200 MD, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00732576
Lead sponsor
Maastricht University Medical Center
First posted
Aug 12, 2008
Start date
Jan 2008
Primary completion
May 2008
Completion
May 2008
Last update
Feb 24, 2017

Study contacts

Cees Vermeer, PhD
principal investigator · Department of Biochemistry, Maastricht University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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