NCT01922804

Brief Summary

The aims of the present study are to investigate the effect of vitamin K2 on bone turnover, bone mass, bone structure, glucose metabolism, and arteriosclerosis. Osteoporosis, diabetes, metabolic syndrome and cardiovascular disease are common diseases that affect large groups of people in the Western world. Our hypotheses is that vitamin K2 (MK-7) reduces undercarboxylated osteocalcin in postmenopausal women and reduces bone turnover and increases bone mineral density; increases insulin sensitivity and decreases indices of arterial calcification.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

July 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 6, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 14, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

October 28, 2016

Status Verified

October 1, 2016

Enrollment Period

3.8 years

First QC Date

August 6, 2013

Last Update Submit

October 27, 2016

Conditions

Metabolic Bone Disorder

Outcome Measures

Primary Outcomes (1)

  • p-undercarboxylated osteocalcin

    Change in undercarboxylated osteocalcin in plasma after 3 month treatment compared to baseline. Analysed in batch after the end of trial.

Secondary Outcomes (5)

  • Change in bone mineral density

    Assessed after 3, 6, 12, 24 and 36 months

  • Change in arterial stiffness, pulse wave velocity

    Measured at baseline and after 6 months

  • Change in insulin sensitivity

    Measured at baseline and after 1 and 12 months.

  • Change in bone turnover markers

    Measured at baseline, after 1, 3, 6, 12, 24 and 36 months

  • Change in bone structure

    baseline and month 12

Study Arms (2)

K2 vitamin

EXPERIMENTAL

K2 vitamin 375 microgram a day for 3 years

Dietary Supplement: K2 vitamin

placebo

PLACEBO COMPARATOR

1 tablet a day for 3 years

Dietary Supplement: Placebo

Interventions

K2 vitaminDIETARY_SUPPLEMENT

K2 vitamin tablet

K2 vitamin
PlaceboDIETARY_SUPPLEMENT

Placebo tablets

placebo

Eligibility Criteria

Age60 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • postmenopausal women
  • years
  • osteopenia

You may not qualify if:

  • Calcium metabolic, thyroid, liver or kidney disease
  • Diabetes
  • Obesity
  • Myocardial infarction or other arteriosclerotic events
  • Angina pectoris
  • Vitamin D \< 50 nmol/L
  • Treatment with vitamin K antagonists
  • Use of vitamin K supplements in the last month or for more than 3 months at any time
  • Treatment with drugs with known effects on bone metabolism or glucose metabolism.
  • Smoking in the last 12 months
  • Drug or alcohol abuse
  • Allergy to calcium, vitamin D or vitamin K.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology and Internal Medicine THG

Aarhus, 8000, Denmark

Location

Related Publications (1)

  • Ronn SH, Harslof T, Oei L, Pedersen SB, Langdahl BL. The effect of vitamin MK-7 on bone mineral density and microarchitecture in postmenopausal women with osteopenia, a 3-year randomized, placebo-controlled clinical trial. Osteoporos Int. 2021 Jan;32(1):185-191. doi: 10.1007/s00198-020-05638-z. Epub 2020 Oct 8.

    PMID: 33030563DERIVED

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Vitamin K 2

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Vitamin KNaphthoquinonesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPhytolDiterpenesTerpenesQuinonesPolycyclic Compounds

Study Officials

  • Sofie Rønn, cand.med

    Aarhus University Hospital

    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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2013

First Posted

August 14, 2013

Study Start

July 1, 2013

Primary Completion

April 1, 2017

Study Completion

April 1, 2018

Last Updated

October 28, 2016

Record last verified: 2016-10

Locations

DK(1)