Biocomparison Study

Bone Health Clinical Trial

Official title:

Comparison of Effects of Nutritional Doses Vitamin K1 and K2 on Carboxylation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01638182
• Other study ID #: 10-3-018
• Status: Completed
• Phase: N/A
• First received: July 9, 2012
• Last updated: July 10, 2012
• Start date: March 2011
• Est. completion date: September 2011

Study information

• Verified date: July 2012
• 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

The effects of two vitamin K-forms on carboxylation of the vitamin K-dependent proteins osteocalcin and matrix-gla protein will be compared after supplementing these vitamins in a nutritional dose range.

The investigators hypothesized that MK-7 is more effective than K1 at a dose comparable to the RDA of vitamin K.

Description:

Vitamin K is a group name for the naturally occurring phylloquinone (K1) and menaquinones (MK-n; K2). The latter can be subdivided into the short-chain (e.g. MK-4) and the long-chain (e.g. MK-7, MK-8, and MK-9) menaquinones. Earlier studies have shown that high vitamin K intake leads to improved bone and vascular health by increased carboxylation of vitamin K-dependent proteins in these tissues. In the dietary range, MK-7 has been suggested to be the most effective cofactor for the carboxylation of Gla-proteins, such as osteocalcin (OC) and matrix-Gla protein (MGP).Until now, no randomized controlled trial has compared the efficacy of K1 versus MK-7 in a nutritional dose range. The investigators are therefore interested to compare the effects of K1 and MK-7 on OC and MGP carboxylation after supplementing these vitamins at a dose not exceeding the RDA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: September 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Healthy men and women, aged between 20-80 years

• Normal body weight and height (18.5 kg/m2 < BMI < 30 kg/m2)

• Stable body weight (weight gain or loss < 3 kg in past 3 mo)

• Written consent to take part in the study

• Agreement to adhere to dietary restrictions required by the protocol

Exclusion Criteria:

• Abuse of drugs and/or alcohol

• Use of vitamin supplements containing vitamin K

• Pregnancy

• (a history of) metabolic or gastrointestinal diseases, e.g. hepatic or renal disorders, osteoporosis

• Chronic degenerative and/or inflammatory diseases, e.g. diabetes mellitus, cancer, cardiovascular disease

• Use of oral anticoagulants, drugs or hormones that influence bone metabolism

• Corticoid treatment

• Subjects with anaemia or subjects who recently donated blood or plasma

• Systemic treatment or topical treatment likely to interfere with coagulation metabolism (salicylates, antibiotics)

Study Design

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

Related Conditions & MeSH terms

• Bone Health
• Vascular Health

Intervention

Dietary Supplement:
• Placebo
27 participants received for three months 1 placebo capsule per day
• Vitamin K1-capsules
27 participants received for 3 months 1 vitamin K1-capsule per day containing 52 µg of K1/day
• Vitamin K2-capsules
27 participants received for 3 months 1 vitamin K2-capsule per day containing 75 µg of MK-7.

Locations

Country	Name	City	State
Netherlands	VitaK BV / Maastricht University Medicial Center	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	carboxylation of osteocalcin	The primary objective of the study is to compare the effects of K1 and MK-7 on circulating ucOC levels after supplementing these vitamins at a nutritional dose.	12 weeks	No
Secondary	carboxylation of matrix-gla protein	The secondary objective of the study is to compare the effects of K1 and MK-7 on circulating ucMGP, which is emerging as a biomarker of arterial calcification.	12 weeks	No