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ISRCTN
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ISRCTN61708241
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DOI
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10.1186/ISRCTN61708241
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ClinicalTrials.gov identifier
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NCT00150969
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EudraCT number
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Public title
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Evaluation of the Clinical use of vitamin K supplementation in post-menopausal women with Osteopenia
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Scientific title
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Evaluation of the clinical use of vitamin K supplementation in post-menopausal women with osteopenia: a randomised controlled trial
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Acronym
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ECKO
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Serial number at source
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MCT-50422
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Study hypothesis
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Vitamin K1 supplementation of 5 mg daily over 2 years can decrease the rate of bone loss in post-menopausal women with osteopenia.
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Lay summary
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Ethics approval
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University Health Network Research Ethics Board, Toronto approved on the 22nd January 2002
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Study design
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Randomised controlled trial
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Osteopenia/osteoporosis
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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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 Paget’s 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
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Anticipated start date
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01/01/2002
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Anticipated end date
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31/08/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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440
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Interventions
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Calcium and vitamin D supplemenation plus 5 mg vitamin K1 or placebo daily for 2 years.
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Primary outcome measure(s)
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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
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Secondary outcome measure(s)
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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
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Sources of funding
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Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-50422)
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Trial website
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Publications
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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
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Contact name
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Dr
Angela
Cheung
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Address
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Toronto General Hospital
657 University Ave
ML1-015
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City/town
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Toronto
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Zip/Postcode
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M5G 2N2
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Country
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Canada
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Tel
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+1 416 340 4301
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Fax
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+1 416 340 4105
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Email
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angela.cheung@uhn.on.ca
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Sponsor
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University Health Network, Toronto (Canada)
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Address
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200 Elizabeth Street
7 Eaton North - 221
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City/town
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Toronto, Ontario
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Zip/Postcode
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M5G 2C4
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Country
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Canada
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Email
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carolynm@uhnresearch.ca
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Sponsor website:
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http://www.uhnresearch.ca
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Date applied
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11/08/2004
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Last edited
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16/11/2009
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Date ISRCTN assigned
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09/09/2005
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