Comparison of Efficacy of Different Dosages Vitamin K2

Carboxylation Level Clinical Trial

Official title:

Comparison of Efficacy of Different Dosages Vitamin K2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01194778
• Other study ID #: 08-3-078
• Status: Completed
• Phase: N/A
• First received: August 5, 2010
• Last updated: September 2, 2010
• Start date: October 2009
• Est. completion date: August 2010

Study information

• Verified date: September 2010
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

Vitamin K is a group name for a number of compounds: K1 is present in chloroplasts in green vegetables, K2 is of microbial origin. Lactic bacteria produce a mixture of higher menaquinones, including menaquinone-7, menaquinone-8, and menaquinone-9. Nothing is known yet about the efficacy of bacterial K2 vitamins for in vivo K function (carboxylation of essential proteins). Therefore, this study was undertaken to study effects of different dosages of bacterial vitamin K2 on carboxylation of extrahepatic proteins.

Description:

Vitamin K is a group name for a number of compounds: K1 is present in chloroplasts in green vegetables, K2 is of microbial origin. Lactic bacteria produce a mixture of higher menaquinones, including menaquinone-7, menaquinone-8, and menaquinone-9. Higher menaquinones not only have very long half-life times (over 3 days rather than 1 hour for vitamin K1); K2 vitamins are also transported to extra hepatic tissues such as bone and vessel wall whereas K1 is preferentially transported to the liver. Nothing is known yet about the efficacy of bacterial K2 vitamins for in vivo K function (carboxylation of essential proteins). This study describes a dose-response experiment for different dosages of bacterial K2 which are compared with one selected dose of K1 and placebo. The efficacy is concluded from the carboxylation of the bone Gla-protein osteocalcin and of the vascular Gla-protein matrix-Gla protein (MGP).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: August 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy men and women between 40 and 60 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 presenting diabetes mellitus

• Abuse of drugs and/or alcohol

• Subjects receiving cortico?d treatment including inhalators

• Subjects using oral anticoagulants

• Subjects using vitamin K containing multivitamins or vitamin K supplements

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carboxylation Level
• Vitamin K-dependent Proteins

Intervention

Dietary Supplement:
• placebo
1 placebo sachet per day containing only sucrose during 12 weeks
• vitamin K1
15 µg vitamin K1 per day during 12 weeks
• vitamin K2
15 µg vitamin K2 per day during 12 weeks
• vitamin K2
30 µg vitamin K2 per day during 12 weeks
• vitamin K2
45 µg vitamin K2 per day during 12 weeks

Locations

Country	Name	City	State
Netherlands	VitaK BV Maastricht University	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The concentration of the circulating biochemical markers matrix-Gla protein and osteocalcin. Both proteins will be measured in their active form (carboxylated form) and their inactive form (undercarboxylated form).	The main purpose of the study is to investigate the efficacy of different dosages bacterial vitamin K2 and vitamin K1 on carboxylation degree of the vitamin K-dependent proteins osteocalcin and matrix-gla protein.	12 weeks	No
Secondary	the number or type of bacteria in the stool	The second purpose of the study is to monitor whether the increased vitamin K intake will change the composition of the intestinal flora, as measured from the collected stools. Vitamin K, notably K2 is produced by a number of colonic bacteria and our principal is interested to learn whether the intake of extra vitamin K will affect the number or type of bacteria in the stool.	12 weeks	No