Status:
COMPLETED
Effect of Vitamin K on Age-Related Bone Loss and Vascular Calcification
Lead Sponsor:
National Institute on Aging (NIA)
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Arthritis Foundation
Conditions:
Osteoporosis
Vascular Calcification
Eligibility:
All Genders
60-80 years
Phase:
PHASE3
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, o...
Eligibility Criteria
Inclusion
- Ambulatory general population
- Dietary intake of vitamin K below 120 mcg
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
452 Patients enrolled
Trial Details
Trial ID
NCT00183001
Start Date
October 1 2001
End Date
October 1 2006
Last Update
February 16 2009
Active Locations (1)
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1
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, United States, 02111