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 (NCT)	NCT00150969
Protocol serial number	MCT-50422
Sponsor	University Health Network, Toronto (Canada)
Funder	Canadian Institutes of Health Research (ref: 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

Toronto General Hospital
657 University Ave
ML1-015
Toronto
M5G 2N2
Canada

Phone	+1 (0)416 340 4301
Email	angela.cheung@uhn.on.ca

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(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
Key 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
Completion date	31/08/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	14/10/2008		Yes	No
Basic results				No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

21/03/2016: added link to results - basic reporting.