Comparison of Absorption of Vitamin K2

Healthy Clinical Trial

Official title:

Comparison of Absorption of Vitamin K2 Human Study Gelpell

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00742768
• Other study ID #: MEC 08-3-012
• Status: Completed
• Phase: N/A
• First received: August 27, 2008
• Last updated: April 25, 2018
• Start date: June 2008
• Est. completion date: August 2008

Study information

• Verified date: March 2009
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

From previous studies it appeared that menaquinone-7 (MK-7) is the most effective form of vitamin K. The Japanese soya product natto is one of the richest food sources of MK-7. However, the taste of natto is not appreciated by the western society. For this reason the active biological compound is produced as a capsule. Different techniques of encapsulation the vitamin can lead to different absorption profiles with intake. Therefore it is important to study influence of type of encapsulation technique on absorption of menaquinone-7.

This study is undertaken to compare absorption of menaquinones between two different encapsulation techniques. Absorption profiles of menaquinone-4 and menaquinone-7 of conventional softgel capsules and newly developed GellpelTM capsules are compared between each other.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 30 Years

Eligibility

Inclusion Criteria:

• Healthy men and women between 20 and 30 years old

• Subjects of normal body weight and height according to BMI < 30

• Subjects of Caucasian race

• Subject has given written consent to take part in the study

Exclusion Criteria:

• Subjects with (a history of) metabolic or gastrointestinal disease

• Subjects presenting chronic degenerative and/or inflammatory disease

• Subjects receiving cortico?d treatment

• Subjects using oral anticoagulants

• Subject with (a history of) soy allergy

• Subjects using vitamin K containing multivitamins or vitamin K supplements

• Subjects with anaemia or subjects who recently donate blood.

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Vitamin K2 in softgel
4 softgel capsules containing 45 µg MK-7 and 5 µg vitamin D3 per capsule and 4 softgel capsules containing 30 µg MK-4 per capsule
• Vitamin K2 in Gelpell
4 Gelpell capsules containing 45 µg MK-7 and 5 µg vitamin D3 per capsule and 4 Gelpell capsules containing 30 µg MK-4 per capsule

Locations

Country	Name	City	State
Netherlands	VitaK BV / Maastricht University	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	VitaK

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean difference in plasma concentration of MK-4 and MK-7 between the two types of capsules (softgel or gelpell)concerns the primary outcome measure.		4 weeks
Secondary	The mean difference in serum concentration of vitamin D3 between the two types of capsules (softgel or gelpell) concerns the secondary endpoint for this study.		4 weeks