Clinical Trial: Effect of Vitamin K on Age-Related Bone Loss and Vascular Calcification

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effect of Vitamin K on Age-Related Bone Loss and Vascular Calcification

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 Summary:

This is a three-year, double-blind, placebo-controlled trial to study the effect of vitamin K supplementation (500 µg/d) 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, 1,25-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 b
Sponsor: National Institute on Aging (NIA)

Current Primary Outcome:

  • 3 year change in bone mineral density at the hip
  • 3 year change in coronary calcification score
  • Hand osteoarthritis score at final visit
  • Concentration and attention scores at final visit


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 3 year change in biochemical measures of vitamin K status
  • 3 year change in bone turnover
  • 3 year change in measures of inflammation
  • Cardiac changes over 3 years
  • Difference in joint symptoms at final visit
  • 3 year change in bone mineral density of the heel, spine and total body


Original Secondary Outcome: Same as current

Information By: National Institute on Aging (NIA)

Dates:
Date Received: September 13, 2005
Date Started: October 2001
Date Completion: October 2006
Last Updated: February 13, 2009
Last Verified: February 2009