Vitamin K in Inflammation and Osteoporosis and Vascular Calcification - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: Vitamin K

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, 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.

Study Type

Interventional

Enrollment

452

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Massachusetts
  - Boston, Massachusetts, United States, 02111
    - Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
3 year change in bone mineral density at the hip
3 year change in coronary calcification score
Hand osteoarthritis score at final visit
Concentration and attention scores at final visit

Secondary Outcome Measures

Outcome Measure
3 year change in biochemical measures of vitamin K status
3 year change in bone turnover
3 year change in measures of inflammation
Cardiac changes over 3 years
Difference in joint symptoms at final visit
3 year change in bone mineral density of the heel, spine and total body

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Aging (NIA)

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

USDA Beltsville Human Nutrition Research Center

Arthritis Foundation

Investigators

Principal Investigator: Sarah L. Booth, PhD, Tufts Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Study Completion

October 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria