12 Dec Vit K Supplementation Study
The overall goal of the study is to help find out if genetic make-up affects how the body stores Vitamin K when Vitamin K intake from the diet changes.
In Phase I of the study, we will test for certain markers in your DNA through a cheek swab to see if you have either the CYP4F2*3 genotype or the CYP4F2*1 genotype. We will then select 14 people each who have these genotypes to take part in the Vitamin K Supplementation portion of the study (Phase II).
In Phase II we will test whether the CYP4F2*3 genotype and other biomarkers in your blood and urine affect the extent of increase in Vitamin K in the body in response to a daily dose of vitamin K.
– If you are a woman of child-bearing potential, have a urine pregnancy test on day 1 (Monday). If the test is positive, we will withdraw you from the study.
– Allow us to collect a small 10 mL (less than 1 tablespoon) fasting blood sample from the vein in your arm every day for 5 days, then on days 8 and 10. We will ask you to come to the UWHS every morning, for 5 consecutive days (Monday through Friday, and then on the following Monday (day 8) and Wednesday (day 10). You must not eat or drink anything that morning before providing this blood sample.
– Allow us to collect a spot fasting urine sample every day for 5 days and then on days 8 and 10 at the UWMC. We will ask you to come to the UWHS on each of these days before eating or drinking anything to provide this urine sample.
– Take a Vitamin K tablet with ½ pint of 2% milk every morning for 10 days. The tablet is 1-mg of phylloquinone (Vitacost; Natures Life K-1 Phylloquinone). We will ask you to take one Vitamin K tablet with milk every morning, for 10 consecutive days (including weekend days).
a. Participants will be males or females 18 years and older in good health (self reported).
b. Participants must read and understand English.
c. Participants must be able to provide informed consent.
d. Women not currently pregnant or lactating.
e. Participants who are not using the drug warfarin.
f. Participants who are not using lipid lowering medications.
g. Participants who do not have high cholesterol (self-reported).
h. Participants who are not lactose intolerant.
i. Participants who weigh at least 110 lbs.
a. Participants less than 18 yrs of age or not in good health (self reported).
b. Participants unable to read and understand English.
c. Participants unable to provide informed consent.
d. Women who are pregnant or lactating.
e. Participants who are using the drug warfarin.
f. Participants who are using lipid lowering medications
g. Participants who have (self-reported) high cholesterol
h. Participants who are lactose intolerant.
i. Participants who do not weigh at least 110 pounds.
For more information and to schedule a Phase I study visit, click here: https://calendly.com/vitamink
Additional Study Details
Full Study Title
Vit K Supplementation Study in Healthy Volunteers (Aim 2B)
Accepts Healthy Volunteers?
University of Washington Health Sciences Building
1959 NE Pacific St. D-254
Seattle, Washington 98195