Evaluation of the Clinical use of vitamin K supplementation in post-menopausal women with Osteopenia
| ISRCTN | ISRCTN61708241 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61708241 |
| ClinicalTrials.gov number | NCT00150969 |
| Secondary identifying numbers | MCT-50422 |
- Submission date
- 11/08/2004
- Registration date
- 09/09/2005
- Last edited
- 21/03/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Angela Cheung
Scientific
Scientific
Toronto General Hospital
657 University Ave
ML1-015
Toronto
M5G 2N2
Canada
| Phone | +1 (0)416 340 4301 |
|---|---|
| angela.cheung@uhn.on.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Evaluation of the clinical use of vitamin K supplementation in post-menopausal women with osteopenia: a randomised controlled trial |
| Study acronym | ECKO |
| Study objectives | 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(s) | University Health Network Research Ethics Board, Toronto, 22/01/2002 |
| Health condition(s) or problem(s) studied | Osteopenia/osteoporosis |
| Intervention | Calcium and vitamin D supplemenation plus 5 mg vitamin K1 or placebo daily for 2 years. |
| Intervention type | Supplement |
| Primary outcome measure | 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 study start date | 01/01/2002 |
| Completion date | 31/08/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 440 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/01/2002 |
| Date of final enrolment | 31/08/2006 |
Locations
Countries of recruitment
- Canada
Study participating centre
Toronto General Hospital
Toronto
M5G 2N2
Canada
M5G 2N2
Canada
Sponsor information
University Health Network, Toronto (Canada)
University/education
University/education
200 Elizabeth Street
7 Eaton North - 221
Toronto, Ontario
M5G 2C4
Canada
| carolynm@uhnresearch.ca | |
| Website | http://www.uhnresearch.ca |
"ROR" |
https://ror.org/026pg9j08 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (ref: MCT-50422)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
- Location
- Canada
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Results article | results | 14/10/2008 | Yes | No |
Editorial Notes
21/03/2016: added link to results - basic reporting.
