Vitamin K Supplementation in Post-Menopausal Osteopenia
This study has been completed.
Sponsor:
University Health Network, Toronto
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00150969
First received: September 6, 2005
Last updated: November 19, 2012
Last verified: November 2012
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Results First Received: January 10, 2012
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Prevention |
| Conditions: |
Post-Menopausal Osteoporosis Post-Menopausal Osteopenia |
| Interventions: |
Dietary Supplement: vitamin K1 (phylloquinone) Dietary Supplement: placebo |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| recruitment from January 2002 to September 2006 through health fairs, community posters and advertisements. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| 453 participants signed consent. 13 were not included in analysis(10 screen failure,3 drop out at baseline) |
Reporting Groups
| Description | |
|---|---|
| Phyloquinone | 5 mg Vitamin K1 |
| Placebo | dummy pill identicle to vitamin k |
Participant Flow for 2 periods
Period 1: 24 Month Main Study
| Phyloquinone | Placebo | |
|---|---|---|
| STARTED | 217 | 223 |
| COMPLETED | 198 | 202 |
| NOT COMPLETED | 19 | 21 |
| Adverse Event | 3 | 4 |
| Death | 1 | 1 |
| Lack of Efficacy | 1 | 8 |
| Lost to Follow-up | 3 | 2 |
| Protocol Violation | 4 | 2 |
| Withdrawal by Subject | 7 | 4 |
Period 2: 24-48 Month Extension
| Phyloquinone | Placebo | |
|---|---|---|
| STARTED | 121 | 140 |
| COMPLETED | 33 | 40 |
| NOT COMPLETED | 88 | 100 |
| Withdrawal by Subject | 6 | 5 |
| Lack of Efficacy | 0 | 1 |
| Adverse Event | 1 | 3 |
| Other Reason | 81 | 91 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Phyloquinone | 5 mg Vitamin K1 |
| Placebo | dummy pill identicle to vitamin k |
| Total | Total of all reporting groups |
Baseline Measures
| Phyloquinone | Placebo | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
217 | 223 | 440 |
|
Age
[units: years] Mean ( Full Range ) |
58.9
( 40.1 to 80.5 ) |
59.2
( 46.1 to 82.3 ) |
59.0
( 40.1 to 82.3 ) |
|
Gender
[1] [units: participant] |
|||
| Female | 217 | 223 | 440 |
| Male | 0 | 0 | 0 |
| [1] | All Participants were community dwelling post-menopausal women |
|---|
Outcome Measures
| 1. Primary: | Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine (L1-L4) Between Treatment Arms. [ Time Frame: 0 to 24 months ] |
| 2. Primary: | Percent Change in Bone Mineral Density (BMD) at the Total Hip Between Treatment Arms. [ Time Frame: 0 to 24 months ] |
| 3. Secondary: | Percent Change in Bone Mineral Density (BMD) at the Femoral Neck Between Treatment Arms. [ Time Frame: 0 to 24 months ] |
| 4. Secondary: | Percent Change in Bone Mineral Density (BMD) at the Ultra-distal Radius Between Treatment Arms. [ Time Frame: 0 to 24 months ] |
| 5. Secondary: | Effect of Vitamin K1 Supplementation on Levels of Bone Formation Marker [ Time Frame: 0-24 months ] |
| 6. Secondary: | Effect of Vitamin K1 Supplementation on Level of Bone Resorption Markers (C-telopeptide: CTX) [ Time Frame: 0-24 months ] |
| 7. Secondary: | Effect of Vitamin K1 Supplementation on Percent of Carboxylation of Osteocalcin [ Time Frame: 0 to 24 months ] |
| 8. Secondary: | Percent Change in Bone Mineral Density (BMD) at the Total Hip Between Treatment Arms. [ Time Frame: 0 to 48 months ] |
| 9. Secondary: | Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine (L1-L4) Between Treatment Arms. [ Time Frame: 0 to 48 months ] |
| 10. Secondary: | Percent Change in Bone Mineral Density (BMD) at the Femoral Neck Between Treatment Arms. [ Time Frame: 0 to 48 months ] |
| 11. Secondary: | Percent Change in Bone Mineral Density (BMD) at the Ultra-distal Radius Between Treatment Arms. [ Time Frame: 0 to 48 months ] |
| 12. Secondary: | Difference in Serious Adverse Events [ Time Frame: up to 48 months ] |
| 13. Secondary: | Difference in Number of New Cancers by Treatment Arm. [ Time Frame: up to 48 months ] |
| 14. Secondary: | Difference in Number of New Clinical Fractures by Treatment Arm. [ Time Frame: up to 48 months ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
Publications of Results:
| All Principal Investigators ARE employed by the organization sponsoring the study. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| Originally designed as a 2-year study with BMD as primary outcome. Thus, the number of women followed to 3 and 4 years was small, and the study was not powered to examine fracture outcomes. |
Results Point of Contact:
Name/Title: Dr. Angela M Cheung
Organization: University Health Network
phone: 416-340-4841
e-mail: jscher@uhnresearch.ca
Organization: University Health Network
phone: 416-340-4841
e-mail: jscher@uhnresearch.ca
Publications of Results:
| ClinicalTrials.gov Identifier: | NCT00150969 History of Changes |
| Other Study ID Numbers: | CIHR-50422 |
| Study First Received: | September 6, 2005 |
| Results First Received: | January 10, 2012 |
| Last Updated: | November 19, 2012 |
| Health Authority: | Canada: Health Canada |