Condition category
Signs and Symptoms
Date applied
30/09/2015
Date assigned
05/10/2015
Last edited
05/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Vitamin K plays a vital role in the body by helping blood to clot and preventing excessive bleeding. It typically comes in two forms: vitamin K1, which is found in leafy green vegetables and vitamin K2, which is found in meat, eggs and cheese. Recent studies have shown that vitamin K2 can help to keep bones healthy and may help to prevent muscle weakness. Falls are one of the leading causes of death and injury in people over the age of 65. Although falls can occur for a variety of reasons, balance problems are thought to play an important role. The aim of this trial is to find out whether vitamin K2 supplements can help to improve balance and reduce the risk of falls in older people.

Who can participate?
Adults aged 65 or over with a history of falls over the last year.

What does the study involve?
Participants are randomly allocated into three groups. The first group take a 400mcg vitamin K2 tablet once a day for 12 months; the second group take a 200mcg vitamin K2 tablet once a day for 12 months and the third group take a placebo tablet (dummy pill) once a day for 12 months. At the end of the 12 months, the balance of all participants is measured at a follow-up appointment by seeing the amount that they sway forwards and backwards on a balance board. At this appointment, participants also have a sample of blood taken to measure the effect of vitamin K in the body as well as having their blood pressure tested while standing up and how well their legs are functioning. They are also asked to provide information about their contact with the health service over the past year.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
1. NHS Tayside (UK)
2. NHS Grampian (UK)
3. NHS Fife (UK)

When is the study starting and how long is it expected to run for?
September 2015 to September 2018

Who is funding the study?
Chief Scientist Office (UK)

Who is the main contact?
Dr Miles Witham

Trial website

Contact information

Type

Public

Primary contact

Dr Miles Witham

ORCID ID

Contact details

Ageing and Health
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom
+44 (0)1382 383086
m.witham@dundee.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2013GR09

Study information

Scientific title

Vitamin K therapy to reduce falls – a pilot randomised controlled trial

Acronym

K-SWAY

Study hypothesis

Main objective:
To test which dose of oral vitamin K2 (200mcg or 400mcg once daily for 1 year) most improves anteroposterior sway compared to placebo.

Secondary objectives:
1. To test whether 1 year of vitamin K2 supplementation (200mcg or 400mcg per day) improves markers of balance, lower limb function and postural blood pressure
2. To test whether 1 year of vitamin K2 supplementation (200mcg or 400mcg per day) reduces falls
3. To assess whether use of oral K2 supplementation (200mcg or 400mcg per day) is associated with a reduction in health and social care utilisation

Ethics approval

East of Scotland Research Ethics Committee, 15/12/2015, approval number: 15/ES/0197

Study design

Multi-centre randomised placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format; please use contact details below to request a participant information sheet

Condition

1. Falls
2. Poor balance

Intervention

Participants are randomly allocated into one of three groups:

Group 1: Receive a daily oral dosing of 400mcg vitamin K2 (MK7 subtype) for a period of 12 months
Group 2: Receive a daily oral 200mcg vitamin K2 (MK7 subtype) for a period of 12 months
Group 3: Receive a daily oral dose of a placebo for a period of 12 months

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

Difference in anterior-posterior sway measured using a balance platform at baseline and 12 months.

Secondary outcome measures

1. Additional markers of postural sway (mediolateral sway, 95% ellipse, RMS, total path length) measured using the AMTI sway meter at baseline, 6 and 12 months
2. Berg balance scale compared between groups at baseline, 6 and 12 months
3. Postural blood pressure drop on standing measured at baseline, 1 and 3 minutes after standing at 6 and 12 months
4. Vitamin K levels are determined by measuring dp-ucMGP levels in the blood at baseline and 12 months
5. Physical function determined with a short physical performance battery, timed up and go test at each time point at baseline, 6 and 12 months
6. Falls frequency determined from monthly falls diary to prospectively record falls
7. Health and social care utilisation data collected using a healthcare data and patient questionnaire at baseline, 6 and 12 months

Overall trial start date

01/09/2015

Overall trial end date

30/09/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 65 years or over
2. Two or more self-reported falls in the previous 12 months OR at least one fall resulting in hospitalisation in the previous 12 months
3. Able (in the Investigators opinion) and willing to comply with all study requirements.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

96

Participant exclusion criteria

1. Unable to give written informed consent
2. Unable to stand without human assistance
3. Atrial fibrillation (as this group should usually be taking warfarin)
4. Taking warfarin (which antagonises vitamin K) or other coumadin derivatives
5. Taking vitamin K supplements
6. Known contraindication to Vitamin K
7. Currently enrolled in another trial (other than observational trials and registries), or within 30 days of completing another trial
8. Currently undertaking physiotherapy or another time-limited supervised non-pharmacological intervention to reduce falls risk
9. Intolerance to soya products

Recruitment start date

01/04/2016

Recruitment end date

31/01/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

NHS Tayside
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom

Trial participating centre

NHS Grampian
Aberdeen Royal Infirmary
Aberdeen
AB25 2ZN
United Kingdom

Trial participating centre

NHS Fife
Victoria Hospital
Kirkcaldy
KY2 5AH
United Kingdom

Sponsor information

Organisation

Tayside Academic Science Centre (UK)

Sponsor details

TASC Research & Development Office
Ninewells Hospital & Medical School
Residency Block
Level 3
George Pirie Way
Dundee
DD1 9SY
United Kingdom
+44 (0)1382 383900
c.forde@dundee.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Chief Scientist Office

Alternative name(s)

CSO

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Main trial results will be published within 12 months of end of trial, via report to funder (CSO, Scottish Government) and in peer-reviewed journal. Results will also be disseminated to participants and their families via a brief written summary and via presentation at study tea-parties.

Intention to publish date

01/09/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

05/04/2016: Ethics approval information added.