Contact information
Type
Scientific
Primary contact
Dr Angela Cheung
ORCID ID
Contact details
Toronto General Hospital
657 University Ave
ML1-015
Toronto
M5G 2N2
Canada
+1 (0)416 340 4301
angela.cheung@uhn.on.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00150969
Protocol/serial number
MCT-50422
Study information
Scientific title
Evaluation of the clinical use of vitamin K supplementation in post-menopausal women with osteopenia: a randomised controlled trial
Acronym
ECKO
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.
Ethics approval
University Health Network Research Ethics Board, Toronto, 22/01/2002
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Osteopenia/osteoporosis
Intervention
Calcium and vitamin D supplemenation plus 5 mg vitamin K1 or placebo daily for 2 years.
Intervention type
Supplement
Phase
Not Applicable
Drug names
Vitamin K
Primary outcome measures
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 measures
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
Overall trial start date
01/01/2002
Overall trial end date
31/08/2006
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
440
Participant 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 Pagets 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
Recruitment start date
01/01/2002
Recruitment end date
31/08/2006
Locations
Countries of recruitment
Canada
Trial participating centre
Toronto General Hospital
Toronto
M5G 2N2
Canada
Sponsor information
Organisation
University Health Network, Toronto (Canada)
Sponsor details
200 Elizabeth Street
7 Eaton North - 221
Toronto
Ontario
M5G 2C4
Canada
-
carolynm@uhnresearch.ca
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (ref: MCT-50422)
Alternative name(s)
Instituts de Recherche en Santé du Canada, CIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Canada
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
See https://clinicaltrials.gov/ct2/show/results/NCT00150969
Publication summary
2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/18922041
Publication citations
-
Results
Cheung AM, Tile L, Lee Y, Tomlinson G, Hawker G, Scher J, Hu H, Vieth R, Thompson L, Jamal S, Josse R, Vitamin K supplementation in postmenopausal women with osteopenia (ECKO trial): a randomized controlled trial., PLoS Med., 2008, 5, 10, e196, doi: 10.1371/journal.pmed.0050196.