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

This study has been completed.
Sponsor:
Collaborators:
Arthritis Foundation
USDA Beltsville Human Nutrition Research Center
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00183001
First received: September 13, 2005
Last updated: February 13, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention Phase
Osteoporosis
Vascular Calcification
Inflammation
Drug: Vitamin K
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effect of Vitamin K on Age-Related Bone Loss and Vascular Calcification

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 452
Study Start Date: October 2001
Estimated Study Completion Date: October 2006
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.

  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00183001

Locations
United States, Massachusetts
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Arthritis Foundation
USDA Beltsville Human Nutrition Research Center
Investigators
Principal Investigator: Sarah L. Booth, PhD Tufts Medical Center
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00183001     History of Changes
Other Study ID Numbers: AG0048, R01 AG19147, R01 HL69272
Study First Received: September 13, 2005
Last Updated: February 13, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
nutritional supplement
dietary supplement
vitamin therapy
Vitamin K deficiency
bone density

Additional relevant MeSH terms:
Calcinosis
Inflammation
Osteoporosis
Vascular Calcification
Bone Diseases
Bone Diseases, Metabolic
Calcium Metabolism Disorders
Metabolic Diseases
Musculoskeletal Diseases
Pathologic Processes
Vitamin K
Vitamins
Antifibrinolytic Agents
Coagulants
Fibrin Modulating Agents
Growth Substances
Hematologic Agents
Hemostatics
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014