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Evaluation of the Clinical use of vitamin K supplementation in post-menopausal women with Osteopenia
ISRCTN ISRCTN61708241
DOI 10.1186/ISRCTN61708241
ClinicalTrials.gov identifier NCT00150969
EudraCT number
Public title Evaluation of the Clinical use of vitamin K supplementation in post-menopausal women with Osteopenia
Scientific title Evaluation of the clinical use of vitamin K supplementation in post-menopausal women with osteopenia: a randomised controlled trial
Acronym ECKO
Serial number at source MCT-50422
Study hypothesis Vitamin K1 supplementation of 5 mg daily over 2 years can decrease the rate of bone loss in post-menopausal women with osteopenia.
Lay summary
Ethics approval University Health Network Research Ethics Board, Toronto approved on the 22nd January 2002
Study design Randomised controlled trial
Countries of recruitment Canada
Disease/condition/study domain Osteopenia/osteoporosis
Participants - inclusion criteria 1. Post-menopausal women with osteopenia
2. Lowest bone mineral density at the total hip, femoral neck and lumbar spine (L1 - L4) between -1.0 and -2.0
3. Post-menopausal defined as one year since the natural cessation of menses, or hysterectomy with either post-menopausal status confirmed by follicle stimulating hormone (FSH) laboratory values, or age 55 and above
4. Osteopenic T-score between -1 and -2 on lumbar, total hip or femoral neck bone mineral density (BMD) measurement. Based on documented BMD done within the past 6 months or BMD measurement done at screening.
Participants - exclusion criteria 1. Women ever having had a fragility fracture after the age of 40
2. Women currently on anticoagulants, previously on anticoagulants in the past 3 months, or expected to be on anticoagulants in the near future
3. Women on hormone replacement therapy, raloxifene, bisphosphonates or calcitonin during the past 3 months
4. Women who have ever been on a bisphosphonate for more than 6 months
5. Women previously diagnosed with Pagetís disease, hyperparathyroidism, hyperthyroidism or other metabolic bone diseases
6. Women with decompensated diseased of the liver, kidney, pancreas, lung or heart; Women with a history of active cancer within the past 5 years
7. Women taking mega-doses of vitamin A (more than 10,000 IU per day) or E (more than 400 IU per day)
8. Women involved in other clinical trials
9. Poor medical or psychiatric risk for the study
Anticipated start date 01/01/2002
Anticipated end date 31/08/2006
Status of trial Completed
Patient information material
Target number of participants 440
Interventions Calcium and vitamin D supplemenation plus 5 mg vitamin K1 or placebo daily for 2 years.
Primary outcome measure(s) Differences in the percent change in Bone Mineral Density at the spine (L1 - L4) and the total hip between treatment and placebo groups measured yearly
Secondary outcome measure(s) 1. Determining potential adverse effects from long-term vitamin K1 supplementation
2. Whether vitamin K1 supplementation affects levels of bone formation markers (serum osteocalcin [OC] and serum bone specific alkaline phosphatase [BAP]) and bone resorption markers (serum N-telopeptide [NTx])
3. Whether vitamin K1 supplementation affects the degree of carboxylation of OC, a major vitamin K-dependent protein in bone
4. Whether vitamin K1 supplementation affects health-related quality of life
5. Whether vitamin K1 supplementation decreases risk of having fragility fractures
6. Whether Apo E modulates the effect of vitamin K1 on bone
Sources of funding Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-50422)
Trial website
Publications 1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18922041
2. Correction in http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0050247
Contact name Dr  Angela  Cheung
  Address Toronto General Hospital
657 University Ave
ML1-015
  City/town Toronto
  Zip/Postcode M5G 2N2
  Country Canada
  Tel +1 416 340 4301
  Fax +1 416 340 4105
  Email angela.cheung@uhn.on.ca
Sponsor University Health Network, Toronto (Canada)
  Address 200 Elizabeth Street
7 Eaton North - 221
  City/town Toronto, Ontario
  Zip/Postcode M5G 2C4
  Country Canada
  Email carolynm@uhnresearch.ca
  Sponsor website: http://www.uhnresearch.ca
Date applied 11/08/2004
Last edited 16/11/2009
Date ISRCTN assigned 09/09/2005
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