Overview

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