Trial Outcomes & Findings for Vitamin K2 Supplementation and Arterial Stiffness in the Renal Transplant Population (The KING Trial) (NCT NCT02517580)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

60 participants

Primary outcome timeframe

8 weeks

Results posted on

2018-02-09

Participant Flow

Participant milestones

Participant milestones
Measure	Vitamin K2 (MK7) Vitamin K2 (MK7) 360 mcg/day PO once daily for 8 weeks
Overall Study STARTED	60
Overall Study COMPLETED	56
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vitamin K2 (MK7) n=60 Participants Vitamin K2 (MK7) 360 mcg/day PO once daily for 8 weeks
Age, Continuous	49.7 years STANDARD_DEVIATION 10.4 • n=60 Participants
Sex: Female, Male Female	26 Participants n=60 Participants
Sex: Female, Male Male	34 Participants n=60 Participants
Region of Enrollment Lebanon	60 participants n=60 Participants
Transplantation duration	15.9 years STANDARD_DEVIATION 6 • n=60 Participants

PRIMARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome measures
Measure	Vitamin K2 (MK7) n=56 Participants Vitamin K2 (MK7) 360 mcg/day PO once daily for 8 weeks Vitamin K2 (MK7)
Reduction From Baseline in Carotid-femoral Pulse Wave Velocity at 8 Weeks	-1.4 m/s Standard Error 0.2

SECONDARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome data not reported

Adverse Events

Vitamin K2 (MK7)

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Vitamin K2 (MK7) n=60 participants at risk Vitamin K2 (MK7) 360 mcg/day PO once daily for 8 weeks Vitamin K2 (MK7)
Gastrointestinal disorders GI symptoms	15.0% 9/60 • Number of events 60 • 10 weeks
Musculoskeletal and connective tissue disorders Leg pain	1.7% 1/60 • Number of events 60 • 10 weeks
Renal and urinary disorders Acute kidney injury	3.3% 2/60 • Number of events 60 • 10 weeks

Additional Information

Dr. Sola Aoun Bahous

Lebanese American University

Phone: +961-1-200-800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place