Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00150969
Status:
COMPLETED
Last Update Posted:
2023-12-28
First Post:
2005-09-06
Brief Title:
Vitamin K Supplementation in Post-Menopausal Osteopenia
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Evaluation of the Clinical Use of Vitamin K Supplementation in Post-Menopausal Women With Osteopenia ECKO Trial
Status:
COMPLETED
Status Verified Date:
2023-12
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:
The purpose of this study is to determine whether supplementation with 5 mg vitamin K daily over a 2-year period will prevent bone loss in post-menopausal women with osteopenia
Detailed Description:
Osteoporosis is major cause of morbidity and mortality in Canadian postmenopausal women It is a systemic disease characterized by low bone mass and deterioration of bone microarchitecture resulting in bone fragility and an increased risk of fractures One in six women over the age of 50 have osteoporosis The lifetime risk of an osteoporotic fracture for an average 50 year-old Canadian woman is 40 The annual health care costs for osteoporotic fractures in Canada have been estimated to exceed 13 billion
Recent data suggest that vitamin K supplements may decrease bone loss and prevent fractures Vitamin K is a co-factor of gamma-glutamyl carboxylase an enzyme that catalyzes the gamma-carboxylation of glutamic acid residues in bone matrix proteins such as osteocalcin Vitamin K has been reported to enhance bone formation in both in vitro studies and in vivo studies in animals Vitamin K levels are low in individuals with osteoporosis and in patients with osteoporotic fractures The few studies examining vitamin K supplementation in humans have showed promising results with no significant side effects but these studies had significant methodological shortcomings such as inadequate sample size and lack of randomization
The primary objective of our study is to examine whether vitamin K supplementation will increase bone mineral density in postmenopausal women with osteopenia Our secondary objectives are to examine the possible adverse effects from long-term vitamin K supplementation to investigate whether vitamin K will decrease risk of fractures and to determine if vitamin K affects quality of life Our hypotheses are that vitamin K increases bone mineral density in postmenopausal women and that there are no significant adverse effects from vitamin K supplementation
Recent data suggest that vitamin K supplements may decrease bone loss and prevent fractures Vitamin K is a co-factor of gamma-glutamyl carboxylase an enzyme that catalyzes the gamma-carboxylation of glutamic acid residues in bone matrix proteins such as osteocalcin Vitamin K has been reported to enhance bone formation in both in vitro studies and in vivo studies in animals Vitamin K levels are low in individuals with osteoporosis and in patients with osteoporotic fractures The few studies examining vitamin K supplementation in humans have showed promising results with no significant side effects but these studies had significant methodological shortcomings such as inadequate sample size and lack of randomization
The primary objective of our study is to examine whether vitamin K supplementation will increase bone mineral density in postmenopausal women with osteopenia Our secondary objectives are to examine the possible adverse effects from long-term vitamin K supplementation to investigate whether vitamin K will decrease risk of fractures and to determine if vitamin K affects quality of life Our hypotheses are that vitamin K increases bone mineral density in postmenopausal women and that there are no significant adverse effects from vitamin K supplementation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 50422 | OTHER_GRANT | Canadian Institute for Health Research CIHR | None |