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

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ClinicalTrials.gov Identifier: NCT00183001
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : February 16, 2009
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Arthritis Foundation
USDA Beltsville Human Nutrition Research Center
Information provided by:
National Institute on Aging (NIA)

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 16, 2005
Last Update Posted Date February 16, 2009
Study Start Date  ICMJE October 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • 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 Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Vitamin K on Age-Related Bone Loss and Vascular Calcification
Official Title  ICMJE 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 Description

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 bone loss, vascular calcification, osteoarthritis and concentration in elderly men and women, above that achieved by supplemental calcium and vitamin D alone.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoporosis
  • Vascular Calcification
  • Inflammation
Intervention  ICMJE Drug: Vitamin K
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 13, 2005)
452
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE October 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ambulatory general population
  • Dietary intake of vitamin K below 120 mcg

Exclusion Criteria:

  • Unable to give informed consent
  • Usual dietary intake of phylloquinone greater than 120 µg/d
  • Usual dietary calcium intake greater than 1500 mg/d
  • Usual dietary vitamin D intake greater than 1500 IU
  • Women less than 5 years postmenopausal
  • Femoral neck BMD (bone mineral density) at screening that is greater than 1.8 SD above or below an age-matched reference mean
  • 24-hour calcium to creatinine ratio exceeding 300 mg/g for women or 350 mg/g for men
  • Terminal illness
  • Renal or liver disease requiring treatment
  • Kidney stone in the past 5 years
  • Current hyperparathyroidism
  • Bilateral hip surgery
  • Treatment with a bisphosphonate, calcitonin, estrogen progestin, androgen, tamoxifen, or fluoride (other than dental rinse), or any other treatment for osteoporosis in previous 3 months
  • Warfarin or anticoagulant use in the past 12 months
  • Nonambulation
  • Known coronary disease, defined by myocardial infarction or unstable angina
  • Prior open heart surgery
  • Atrial fibrillation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00183001
Other Study ID Numbers  ICMJE AG0048
R01AG019147 ( U.S. NIH Grant/Contract )
R01HL069272 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Institute on Aging (NIA)
Collaborators  ICMJE
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Arthritis Foundation
  • USDA Beltsville Human Nutrition Research Center
Investigators  ICMJE
Principal Investigator: Sarah L. Booth, PhD Tufts Medical Center
PRS Account National Institute on Aging (NIA)
Verification Date February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP