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

Completed · Phase 3

Conditions studied: Osteoporosis, Vascular Calcification, Inflammation

In brief

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.

Key facts

Study ID: NCT00183001
Run by: National Institute on Aging (NIA)
People needed: 452
Starts: 2001-10-01
Expected to finish: 2006-10-01
Last updated by the study team: 2009-02-16

Who can join

Age: 60 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Ambulatory general population
Dietary intake of vitamin K below 120 mcg

You may not qualify if…

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

Where it is running

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.