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Sponsors and Collaborators: |
National Institute on Aging (NIA) National Heart, Lung, and Blood Institute (NHLBI) Arthritis Foundation USDA Agricultural Research Service (ARS) |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00183001 |
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 |
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Osteoporosis Vascular Calcification Inflammation |
Drug: Vitamin K |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Effect of Vitamin K on Age-Related Bone Loss and Vascular Calcification |
Estimated Enrollment: | 452 |
Study Start Date: | October 2001 |
Estimated Study Completion Date: | October 2006 |
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.
Ages Eligible for Study: | 60 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University | |
Boston, Massachusetts, United States, 02111 |
Principal Investigator: | Sarah L. Booth, PhD | Tufts Medical Center |
Study ID Numbers: | AG0048, R01 AG19147, R01 HL69272 |
Study First Received: | September 13, 2005 |
Last Updated: | September 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00183001 |
Health Authority: | United States: Federal Government |
nutritional supplement dietary supplement vitamin therapy Vitamin K deficiency bone density |
Calcinosis Antiplasmin Metabolic Diseases Musculoskeletal Diseases Vitamin K |
Osteoporosis Bone Diseases, Metabolic Metabolic disorder Bone Diseases Inflammation |
Molecular Mechanisms of Pharmacological Action Coagulants Growth Substances Physiological Effects of Drugs Hematologic Agents Pharmacologic Actions Hemostatics |
Calcium Metabolism Disorders Fibrin Modulating Agents Pathologic Processes Antifibrinolytic Agents Therapeutic Uses Vitamins Micronutrients |