NCT00183001

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
452

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2001

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

February 16, 2009

Status Verified

February 1, 2009

First QC Date

September 13, 2005

Last Update Submit

February 13, 2009

Conditions

OsteoporosisVascular CalcificationInflammation

Keywords

nutritional supplementdietary supplementvitamin therapyVitamin K deficiencybone density

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Interventions

Vitamin KDRUG

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Boston, Massachusetts, 02111, United States

Location

Related Publications (14)

  • 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.

    PMID: 14500910BACKGROUND

  • 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.

    PMID: 8849401BACKGROUND

  • 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.

    PMID: 15472183BACKGROUND

  • 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.

    PMID: 16973975RESULT

  • 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.

    PMID: 23719555DERIVED

  • 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.

    PMID: 22955514DERIVED

  • 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.

    PMID: 21628633DERIVED

  • 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.

    PMID: 20719580DERIVED

  • 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.

    PMID: 20237066DERIVED

  • 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.

    PMID: 19776145DERIVED

  • 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.

    PMID: 19386744DERIVED

  • 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.

    PMID: 18697901DERIVED

  • 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.

    PMID: 18689371DERIVED

  • 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.

    PMID: 18625626DERIVED

MeSH Terms

Conditions

OsteoporosisVascular CalcificationInflammationVitamin K Deficiency

Interventions

Vitamin K

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesCalcinosisCalcium Metabolism DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersAvitaminosisDeficiency DiseasesMalnutritionNutrition Disorders

Intervention Hierarchy (Ancestors)

NaphthoquinonesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPhytolDiterpenesTerpenesPolycyclic Compounds

Study Officials

  • Sarah L. Booth, PhD

    Tufts Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

October 1, 2001

Study Completion

October 1, 2006

Last Updated

February 16, 2009

Record last verified: 2009-02

Locations

US(1)