Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00483431
Status:
COMPLETED
Last Update Posted:
2018-04-27
First Post:
2007-06-06
Brief Title:
Dose-finding Study for Vitamin K2 in Human Volunteers
Sponsor:
Maastricht University Medical Center
Organization:
Maastricht University Medical Center
Study Overview
Official Title:
Dose-finding Study for Vitamin K2 in Human Volunteers
Status:
COMPLETED
Status Verified Date:
2009-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Earlier studies have shown that high vitamin K-intake leads to improved bone and vascular health by increased carboxylation of Gla-proteins in these tissues From all K-vitamins Menaquinone-7 MK7 has been identified as the most effective cofactor for the carboxylation reaction of Gla-proteins such as osteocalcin and matrix-gla protein The question remains which dosage of MK7 leads to optimal carboxylation levels of these proteins
The primary objective of this double-blind randomized intervention study is to establish the optimal dose of MK7 for carboxylation of the vitamin K-dependent proteins osteocalcin in bone and matrix-gla protein in the vessel wall The optimal dose will be the concentration at which osteocalcin and matrix-gla protein are 90 in the active carboxylated form
The primary objective of this double-blind randomized intervention study is to establish the optimal dose of MK7 for carboxylation of the vitamin K-dependent proteins osteocalcin in bone and matrix-gla protein in the vessel wall The optimal dose will be the concentration at which osteocalcin and matrix-gla protein are 90 in the active carboxylated form
Detailed Description:
This study is a double-blind randomized intervention study In total 42 healthy volunteers men and women between 18 and 45 years will be recruited among the Maastricht University community coworkersstudents and randomized into one of the following groups
Placebo 10 mcg MK7 20 mcg MK7 45 mcg MK7 90 mcg MK7 180 mcg MK7 360 mcg MK7
Each group will consist of 6 volunteers with approximately equal numbers of men and women 3 men 3 women A double-blind design of the study is chosen to avoid the occurrence of bias during the study The randomization procedure will be performed by an investigator who is not involved in the coordination of the study and will generate specific randomization codes for each subject After randomization the volunteers consume the indicated amount of capsules once daily with either breakfast of dinner during a period of 12 weeks
During the first week blood samples of the volunteers will be collected at day 0 1 3 and 7 to study immediate effects on carboxylation of OC and MGP After the first week blood samples will be drawn every first day of week 2 4 6 8 10 and 12
Placebo 10 mcg MK7 20 mcg MK7 45 mcg MK7 90 mcg MK7 180 mcg MK7 360 mcg MK7
Each group will consist of 6 volunteers with approximately equal numbers of men and women 3 men 3 women A double-blind design of the study is chosen to avoid the occurrence of bias during the study The randomization procedure will be performed by an investigator who is not involved in the coordination of the study and will generate specific randomization codes for each subject After randomization the volunteers consume the indicated amount of capsules once daily with either breakfast of dinner during a period of 12 weeks
During the first week blood samples of the volunteers will be collected at day 0 1 3 and 7 to study immediate effects on carboxylation of OC and MGP After the first week blood samples will be drawn every first day of week 2 4 6 8 10 and 12
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None