Comparison of Efficacy of Different Dosages Vitamin K2

NCT01194778 | Completed

• 1 other identifier: 08-3-078
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carboxylation Level; Vitamin K-dependent Proteins

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• the number or type of bacteria in the stool

  12 weeks

Study Arms (5)

placebo

PLACEBO COMPARATOR

The participants of the placebo group will receive daily 1 placebo sachet containing only sucrose

Dietary Supplement: placebo

vitamin K1

ACTIVE COMPARATOR

The participants of this group will receive daily 1 sachet containing 15 µg vitamin K1.

Dietary Supplement: vitamin K1

vitamin K2 - 15 µg

ACTIVE COMPARATOR

The participants of this group will receive daily 1 sachet containing 15 µg vitamin K2

Dietary Supplement: vitamin K2

vitamin K2 - 30 µg

ACTIVE COMPARATOR

The participants of this group will receive daily 1 sachet containing 30 µg vitamin K2

Dietary Supplement: vitamin K2

vitamin K2 - 45 µg

ACTIVE COMPARATOR

The participants of this group will receive daily 1 sachet containing 45 µg vitamin K2.

Dietary Supplement: vitamin K2

Interventions

placebo DIETARY_SUPPLEMENT

1 placebo sachet per day containing only sucrose during 12 weeks

placebo

vitamin K1 DIETARY_SUPPLEMENT

15 µg vitamin K1 per day during 12 weeks

vitamin K1

vitamin K2 DIETARY_SUPPLEMENT

15 µg vitamin K2 per day during 12 weeks

vitamin K2 - 15 µg

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 corticoϊd treatment including inhalators
• Subjects using oral anticoagulants
• Subjects using vitamin K containing multivitamins or vitamin K supplements

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

VitaK BV Maastricht University

Maastricht, 6229 EV, Netherlands

Location

MeSH Terms

Interventions

Vitamin K 1; Vitamin K 2

Intervention Hierarchy (Ancestors)

Vitamin K; Naphthoquinones; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phytol; Diterpenes; Terpenes; Quinones; Polycyclic Compounds

Study Officials

• Cees Vermeer, PhD

  VitaK BV Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 5, 2010
• First Posted: September 3, 2010
• Study Start: October 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: August 1, 2010
• Last Updated: September 3, 2010

Record last verified: 2010-09

Locations

NL (1)