NCT00732576

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 12, 2008

Completed
Last Updated

February 24, 2017

Status Verified

March 1, 2009

Enrollment Period

4 months

First QC Date

October 10, 2007

Last Update Submit

February 22, 2017

Conditions

Atherosclerosis

Keywords

CardiovascularCalcification

Outcome Measures

Primary Outcomes (1)

  • Endogenous Thrombin Potential (ETP)

    12 weeks

Secondary Outcomes (2)

  • Osteocalcin carboxylation

    12 weeks

  • Matrix Gla-protein carboxylation

    12 weeks

Study Arms (8)

1

ACTIVE COMPARATOR

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

Dietary Supplement: fish oil

2

ACTIVE COMPARATOR

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-7Dietary Supplement: fish oil

3

ACTIVE COMPARATOR

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-7Dietary Supplement: fish oil

4

ACTIVE COMPARATOR

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-7Dietary Supplement: fish oil

5

ACTIVE COMPARATOR

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

Dietary Supplement: krill oil

6

ACTIVE COMPARATOR

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-7Dietary Supplement: krill oil

7

ACTIVE COMPARATOR

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-7Dietary Supplement: krill oil

8

ACTIVE COMPARATOR

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-7Dietary Supplement: krill oil

Interventions

menaquinone-7DIETARY_SUPPLEMENT

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

Also known as: MenaQ7
234678
fish oilDIETARY_SUPPLEMENT

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

1234
krill oilDIETARY_SUPPLEMENT

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

5678

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VitaK - Maastricht University

Maastricht, 6200 MD, Netherlands

Location

MeSH Terms

Conditions

AtherosclerosisCalcinosis

Interventions

menaquinone 7Fish Oils

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

OilsLipids

Study Officials

  • Cees Vermeer, PhD

    Department of Biochemistry, Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 10, 2007

First Posted

August 12, 2008

Study Start

January 1, 2008

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

February 24, 2017

Record last verified: 2009-03

Locations

NL(1)