Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00183001
Status:
COMPLETED
Last Update Posted:
2009-02-16
First Post:
2005-09-13
Brief Title:
Effect of Vitamin K on Age-Related Bone Loss and Vascular Calcification
Sponsor:
National Institute on Aging NIA
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
Effect of Vitamin K on Age-Related Bone Loss and Vascular Calcification
Status:
COMPLETED
Status Verified Date:
2009-02
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 if supplemental vitamin K will reduce age-related bone loss in elderly men and women above that achieved by supplementation
Detailed Description:
This is a three-year double-blind placebo-controlled trial to study the effect of vitamin K supplementation 500 µgd on bone density at the hip markers of bone turnover vascular calcification osteoarthritis and tests of concentration in 452 men and women aged 60-80 years All participants will also be receiving calcium and vitamin D supplements in addition to a multivitamin to prevent any potential bone loss associated with dietary inadequacy of these nutrients
Measurements of plasma vitamin K concentrations percent undercarboxylated osteocalcin markers of vitamin K status serum osteocalcin collagen Type-I-crosslink N-telopeptides markers of bone turnover and BMD of the hip as well as the heel spine and total body at 0 6 12 24 and 36 months of vitamin K supplementation Vascular calcification will be measured at baseline and at 36 months of vitamin K supplementation by multi-slice CT scan An additional EKG will be performed at 36 months of vitamin K supplementation to determine cardiac changes that may have occurred over the course of the study Bilateral hand x-rays will be measured at 36 months of vitamin K supplementation as will the administration of the Framingham OA questionnaire Plasma 25-hydroxyvitamin D concentrations and urinary calcium and sodium will be measured at the same time points to be used as covariates in this assessment In addition 125-dihydroxyvitamin D will be measured at the beginning and end of the study Other covariates collected throughout the study include age weight anthropometric data physical activity medication used smoking plasma lipids insulin and measures of inflammation B vitamins and dietary intakes In addition two tests of attention and concentration will be administered at 36 months of vitamin K supplementation This trial will determine if supplemental vitamin K will reduce age-related bone loss vascular calcification osteoarthritis and concentration in elderly men and women above that achieved by supplemental calcium and vitamin D alone
Measurements of plasma vitamin K concentrations percent undercarboxylated osteocalcin markers of vitamin K status serum osteocalcin collagen Type-I-crosslink N-telopeptides markers of bone turnover and BMD of the hip as well as the heel spine and total body at 0 6 12 24 and 36 months of vitamin K supplementation Vascular calcification will be measured at baseline and at 36 months of vitamin K supplementation by multi-slice CT scan An additional EKG will be performed at 36 months of vitamin K supplementation to determine cardiac changes that may have occurred over the course of the study Bilateral hand x-rays will be measured at 36 months of vitamin K supplementation as will the administration of the Framingham OA questionnaire Plasma 25-hydroxyvitamin D concentrations and urinary calcium and sodium will be measured at the same time points to be used as covariates in this assessment In addition 125-dihydroxyvitamin D will be measured at the beginning and end of the study Other covariates collected throughout the study include age weight anthropometric data physical activity medication used smoking plasma lipids insulin and measures of inflammation B vitamins and dietary intakes In addition two tests of attention and concentration will be administered at 36 months of vitamin K supplementation This trial will determine if supplemental vitamin K will reduce age-related bone loss vascular calcification osteoarthritis and concentration in elderly men and women above that achieved by supplemental calcium and vitamin D alone
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL069272 | NIH | None | httpsreporternihgovquickSearchR01HL069272 |
| R01AG019147 | NIH | None | None |