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

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute on Aging (NIA)
• Collaborators: Arthritis Foundation; National Heart, Lung, and Blood Institute (NHLBI); USDA Beltsville Human Nutrition Research Center
• Treatments: Vitamin K; Vitamins

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