Trial Outcomes & Findings for Determinants of Vitamin K Metabolism (NCT NCT00336232)

NCT ID: NCT00336232

Last Updated: 2023-11-29

Results Overview

Plasma phylloquinone in response to phylloquinone depletion and repletion

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 59 participants
• Primary outcome timeframe: 2 months
• Results posted on: 2023-11-29

Participant Flow

Participant milestones

Measure	Vitamin K Diet Intervention 5 day baseline vitamin K Vitamin K: phylloquinone (vitamin K1) 200 mcg daily 28 day diet low vitamin K Vitamin K: phylloquinone (vitamin K1) approx. 10 mcg daily for 28 days treatment started day 6, completed day 33 28 day diet high vitamin K Vitamin K: phylloquinone (vitamin K1) 500 mcg daily in third month treatment started day 34, ended day 61
Baseline (200mcg Daily) STARTED	59
Baseline (200mcg Daily) COMPLETED	42
Baseline (200mcg Daily) NOT COMPLETED	17
Low Vitamin K (10mcg Daily) STARTED	42
Low Vitamin K (10mcg Daily) COMPLETED	42
Low Vitamin K (10mcg Daily) NOT COMPLETED	0
High Vitamin K (500mcg Daily) STARTED	42
High Vitamin K (500mcg Daily) COMPLETED	42
High Vitamin K (500mcg Daily) NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Determinants of Vitamin K Metabolism

Baseline characteristics by cohort

Measure	Diet Intervention n=42 Participants 5 day baseline vitamin K Vitamin K: phylloquinone (vitamin K1) 200 mcg daily 28 day diet low vitamin K Vitamin K: phylloquinone (vitamin K1) approx. 10 mcg daily for 28 days treatment started day 6, completed day 33 28 day diet high vitamin K Vitamin K: phylloquinone (vitamin K1) 500 mcg daily in third month treatment started day 34, ended day 61
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants
Plasma phylloquinone (nmol/L)	0.8 nmol/L STANDARD_DEVIATION 1.1 • n=5 Participants

PRIMARY outcome

Timeframe: 2 months

Plasma phylloquinone in response to phylloquinone depletion and repletion

Outcome measures

Measure	Diet Intervention n=42 Participants 5 day baseline vitamin K Vitamin K: phylloquinone (vitamin K1) 200 mcg daily 28 day diet low vitamin K Vitamin K: phylloquinone (vitamin K1) approx. 10 mcg daily for 28 days treatment started day 6, completed day 33 28 day diet high vitamin K Vitamin K: phylloquinone (vitamin K1) 500 mcg daily in third month treatment started day 34, ended day 61
Plasma Phylloquinone low vitamin K	0.3 nmol/L Standard Deviation 0.6
Plasma Phylloquinone high vitamin K	2.3 nmol/L Standard Deviation 1.4

Adverse Events

Diet Intervention

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Diet Intervention n=42 participants at risk 5 day baseline vitamin K Vitamin K: phylloquinone (vitamin K1) 200 mcg daily 28 day diet low vitamin K Vitamin K: phylloquinone (vitamin K1) approx. 10 mcg daily for 28 days treatment started day 6, completed day 33 28 day diet high vitamin K Vitamin K: phylloquinone (vitamin K1) 500 mcg daily in third month treatment started day 34, ended day 61
Blood and lymphatic system disorders High blood pressure	2.4% 1/42 • Number of events 1 • duration of study, up to 62 days
Blood and lymphatic system disorders History of blood clotting	2.4% 1/42 • Number of events 1 • duration of study, up to 62 days
General disorders Facial swelling	2.4% 1/42 • Number of events 1 • duration of study, up to 62 days

Additional Information

Sarah Booth, PhD

Tufts University

Phone: 617-556-3231

Email: sarah.booth@tufts.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place