Condition category
Musculoskeletal Diseases
Date applied
11/08/2004
Date assigned
09/09/2005
Last edited
21/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 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

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

http://www.uhnresearch.ca

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

  1. 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.

Additional files

Editorial Notes

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