Using vitamin K to improve strength and balance in older people

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18436190

Enrollment

Registered

2015-10-05

Start date

2016-04-01

Completion date

Unknown

Last updated

2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of falls and loss of balance in older people Signs and Symptoms 1. Falls 2. Poor balance

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

United Kingdom

Contacts

Public ContactMiles Witham

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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026