Using vitamin K to improve strength and balance in older people

ISRCTN	ISRCTN18436190
DOI	https://doi.org/10.1186/ISRCTN18436190
Protocol serial number	2013GR09
Sponsor	Tayside Academic Science Centre (UK)
Funder	Chief Scientist Office

Submission date: 30/09/2015
Registration date: 05/10/2015
Last edited: 20/08/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Miles Witham
Public

NIHR Newcastle Biomedical Research Centre
Biomedical Research Building
Campus for Ageing and Vitality
Newcastle
NE4 5PL
United Kingdom

Phone	+44 (0)191 208 1317
Email	Miles.Witham@newcastle.ac.uk

Study information

Primary study design	Interventional
Study design	Multi-centre randomised placebo-controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Vitamin K therapy to reduce falls – a pilot randomised controlled trial
Study acronym	K-SWAY
Study objectives	Main objective: To test which dose of oral vitamin K2 (200 mcg or 400 mcg once daily for 1 year) most improves anteroposterior sway compared to placebo. Secondary objectives: 1. To test whether 1 year of vitamin K2 supplementation (200 mcg or 400 mcg per day) improves markers of balance, lower limb function and postural blood pressure 2. To test whether 1 year of vitamin K2 supplementation (200 mcg or 400 mcg per day) reduces falls 3. To assess whether use of oral K2 supplementation (200 mcg or 400 mcg per day) is associated with a reduction in health and social care utilisation
Ethics approval(s)	East of Scotland Research Ethics Committee, 15/12/2015, approval number: 15/ES/0197
Health condition(s) or problem(s) studied	Prevention of falls and loss of balance in older people
Intervention	Participants are randomly allocated into one of three groups: Group 1: Receive a daily oral dosing of 400 mcg vitamin K2 (MK7 subtype) for a period of 12 months Group 2: Receive a daily oral 200 mcg 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
Primary outcome measure(s)	Difference in anterior-posterior sway measured using a balance platform at baseline and 12 months.
Key secondary outcome measure(s)	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
Completion date	30/09/2018

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	96
Total final enrolment	95
Key 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.
Key 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
Date of first enrolment	01/04/2016
Date of final enrolment	31/01/2017

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centres

NHS Tayside

Ninewells Hospital
Dundee
DD1 9SY
United Kingdom

NHS Grampian

Aberdeen Royal Infirmary
Aberdeen
AB25 2ZN
United Kingdom

NHS Fife

Victoria Hospital
Kirkcaldy
KY2 5AH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	Participant level, anonymised data will be available for sharing with bona-fide academic groups, subject to submission and approval of an analysis plan by a data access committee led by the Sponsor. Please contact Professor Witham or the Sponsor (TASCgovernance@dundee.ac.uk) to discuss proposals for data sharing.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results of study within a trial (SWAT) comparing two participant information sheets	01/12/2018	08/10/2019	Yes	No
Results article		18/06/2019	20/08/2021	Yes	No
Basic results		14/01/2018	14/01/2019	No	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Additional files

ISRCTN18436190_BasicResults_14Jan2018.pdf: Uploaded 14/01/2019

Editorial Notes

20/08/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
17/03/2020: Internal review.
08/10/2019: Publication reference added.
14/01/2018: The following changes were made to the trial record:
1. Contact details updated.
2. IPD sharing statement added.
3. The basic results of this trial have been uploaded as an additional file.
05/04/2016: Ethics approval information added.