AzTrials
AzTrials

OsteoporosisPhase 3NCT00183001

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

A Phase 3 study testing Vitamin K in people with Osteoporosis and Vascular Calcification, run by National Institute on Aging (NIA) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 60 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Osteoporosis, Vascular Calcification, Inflammation
What is being tested?
Vitamin K
How many people
452 participants
Where
1 siteUnited States
Study dates
Oct 2001to Oct 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Ambulatory general population
  • Dietary intake of vitamin K below 120 mcg

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

    Boston, Massachusetts, 02111

Other trials in United States

About this study

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.

Read the 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.

Being tested
Vitamin K
Keywords
nutritional supplement, dietary supplement, vitamin therapy, Vitamin K deficiency, bone density
Medical subject headings
Osteoporosis, Vascular Calcification, Inflammation, Vitamin K Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin KDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 3 year change in bone mineral density at the hip

  2. 3 year change in coronary calcification score

  3. Hand osteoarthritis score at final visit

  4. Concentration and attention scores at final visit

Secondary outcomes (6)

  1. 3 year change in biochemical measures of vitamin K status

  2. 3 year change in bone turnover

  3. 3 year change in measures of inflammation

  4. Cardiac changes over 3 years

  5. Difference in joint symptoms at final visit

  6. 3 year change in bone mineral density of the heel, spine and total body

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2005 (estimated)
  2. Study startOct 2001
  3. Study completionOct 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
452 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00183001
Sponsor's protocol ID
AG0048
Other IDs
R01AG019147, R01HL069272
Status last verified
Feb 2009
First submitted
13 Sep 2005
Last updated
16 Feb 2009
Results posted
No

Publications

  • Doherty TM, Asotra K, Fitzpatrick LA, Qiao JH, Wilkin DJ, Detrano RC, Dunstan CR, Shah PK, Rajavashisth TB. Calcification in atherosclerosis: bone biology and chronic inflammation at the arterial crossroads. Proc Natl Acad Sci U S A. 2003 Sep 30;100(20):11201-6. doi: 10.1073/pnas.1932554100. Epub 2003 Sep 19.

    PubMed 14500910

  • Jie KG, Bots ML, Vermeer C, Witteman JC, Grobbee DE. Vitamin K status and bone mass in women with and without aortic atherosclerosis: a population-based study. Calcif Tissue Int. 1996 Nov;59(5):352-6. doi: 10.1007/s002239900139.

    PubMed 8849401

  • Booth SL, Broe KE, Peterson JW, Cheng DM, Dawson-Hughes B, Gundberg CM, Cupples LA, Wilson PW, Kiel DP. Associations between vitamin K biochemical measures and bone mineral density in men and women. J Clin Endocrinol Metab. 2004 Oct;89(10):4904-9. doi: 10.1210/jc.2003-031673.

    PubMed 15472183

  • O'Donnell CJ, Shea MK, Price PA, Gagnon DR, Wilson PW, Larson MG, Kiel DP, Hoffmann U, Ferencik M, Clouse ME, Williamson MK, Cupples LA, Dawson-Hughes B, Booth SL. Matrix Gla protein is associated with risk factors for atherosclerosis but not with coronary artery calcification. Arterioscler Thromb Vasc Biol. 2006 Dec;26(12):2769-74. doi: 10.1161/01.ATV.0000245793.83158.06. Epub 2006 Sep 14.

    PubMed 16973975

  • Shea MK, Booth SL, Miller ME, Burke GL, Chen H, Cushman M, Tracy RP, Kritchevsky SB. Association between circulating vitamin K1 and coronary calcium progression in community-dwelling adults: the Multi-Ethnic Study of Atherosclerosis. Am J Clin Nutr. 2013 Jul;98(1):197-208. doi: 10.3945/ajcn.112.056101. Epub 2013 May 29.

    PubMed 23719555

  • Ma J, Ross AB, Shea MK, Bruce SJ, Jacques PF, Saltzman E, Lichtenstein AH, Booth SL, McKeown NM. Plasma alkylresorcinols, biomarkers of whole-grain intake, are related to lower BMI in older adults. J Nutr. 2012 Oct;142(10):1859-64. doi: 10.3945/jn.112.163253. Epub 2012 Sep 5.

    PubMed 22955514

  • Shea MK, O'Donnell CJ, Vermeer C, Magdeleyns EJ, Crosier MD, Gundberg CM, Ordovas JM, Kritchevsky SB, Booth SL. Circulating uncarboxylated matrix gla protein is associated with vitamin K nutritional status, but not coronary artery calcium, in older adults. J Nutr. 2011 Aug;141(8):1529-34. doi: 10.3945/jn.111.139634. Epub 2011 May 31.

    PubMed 21628633

  • Al Rajabi A, Peterson J, Choi SW, Suttie J, Barakat S, Booth SL. Measurement of menadione in urine by HPLC. J Chromatogr B Analyt Technol Biomed Life Sci. 2010 Sep 15;878(26):2457-60. doi: 10.1016/j.jchromb.2010.07.016. Epub 2010 Jul 29.

    PubMed 20719580

  • Shea MK, Booth SL, Gundberg CM, Peterson JW, Waddell C, Dawson-Hughes B, Saltzman E. Adulthood obesity is positively associated with adipose tissue concentrations of vitamin K and inversely associated with circulating indicators of vitamin K status in men and women. J Nutr. 2010 May;140(5):1029-34. doi: 10.3945/jn.109.118380. Epub 2010 Mar 17.

    PubMed 20237066

  • Shea MK, Gundberg CM, Meigs JB, Dallal GE, Saltzman E, Yoshida M, Jacques PF, Booth SL. Gamma-carboxylation of osteocalcin and insulin resistance in older men and women. Am J Clin Nutr. 2009 Nov;90(5):1230-5. doi: 10.3945/ajcn.2009.28151. Epub 2009 Sep 23.

    PubMed 19776145

  • Shea MK, O'Donnell CJ, Hoffmann U, Dallal GE, Dawson-Hughes B, Ordovas JM, Price PA, Williamson MK, Booth SL. Vitamin K supplementation and progression of coronary artery calcium in older men and women. Am J Clin Nutr. 2009 Jun;89(6):1799-807. doi: 10.3945/ajcn.2008.27338. Epub 2009 Apr 22.

    PubMed 19386744

  • Yoshida M, Jacques PF, Meigs JB, Saltzman E, Shea MK, Gundberg C, Dawson-Hughes B, Dallal G, Booth SL. Effect of vitamin K supplementation on insulin resistance in older men and women. Diabetes Care. 2008 Nov;31(11):2092-6. doi: 10.2337/dc08-1204. Epub 2008 Aug 12.

    PubMed 18697901

  • Shea MK, Dallal GE, Dawson-Hughes B, Ordovas JM, O'Donnell CJ, Gundberg CM, Peterson JW, Booth SL. Vitamin K, circulating cytokines, and bone mineral density in older men and women. Am J Clin Nutr. 2008 Aug;88(2):356-63. doi: 10.1093/ajcn/88.2.356.

    PubMed 18689371

  • Neogi T, Felson DT, Sarno R, Booth SL. Vitamin K in hand osteoarthritis: results from a randomised clinical trial. Ann Rheum Dis. 2008 Nov;67(11):1570-3. doi: 10.1136/ard.2008.094771. Epub 2008 Jul 14.

    PubMed 18625626

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vitamin K in people with Osteoporosis and Vascular Calcification, run by National Institute on Aging (NIA) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3 year change in bone mineral density at the hip. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00183001, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2009.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in