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Biocomparison Study

Information source: Maastricht University Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bone Health; Vascular Health

Intervention: Placebo (Dietary Supplement); Vitamin K1-capsules (Dietary Supplement); Vitamin K2-capsules (Dietary Supplement)

Phase: N/A

Status: Completed

Sponsored by: Maastricht University Medical Center

Official(s) and/or principal investigator(s):
Cees Vermeer, PhD, Principal Investigator, Affiliation: VitaK BV Maastricht University

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.

Clinical Details

Official title: Comparison of Effects of Nutritional Doses Vitamin K1 and K2 on Carboxylation

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

Primary outcome: carboxylation of osteocalcin

Secondary outcome: carboxylation of matrix-gla protein

Detailed 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.

Eligibility

Minimum age: 20 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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)

Locations and Contacts

VitaK BV / Maastricht University Medicial Center, Maastricht, Netherlands
Additional Information

Starting date: March 2011
Last updated: July 10, 2012

Page last updated: August 23, 2015

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