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| Name | Class |
|---|---|
| Omicron Pharmaceuticals | INDUSTRY |
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This study is a single arm, single center clinical trial that aims to evaluate the effect of 8 weeks of vitamin K2 replacement (360 mcg/day) on the progression of arterial stiffness in stable renal transplant patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin K2 (MK7) | Experimental | Vitamin K2 (MK7) 360 mcg/day PO once daily for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin K2 (MK7) | Dietary Supplement |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction From Baseline in Carotid-femoral Pulse Wave Velocity at 8 Weeks | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Central Pressure by Ambulatory Hemodynamic Measurement (Mobil-O-Graph) at 8 Weeks | 8 weeks | |
| Change From Baseline in Augmentation Index by Ambulatory Hemodynamic Measurement (Mobil-O-Graph) at 8 Weeks | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sola Aoun Bahous, M.D. Ph.D. | Lebanese American University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lebanese American University Medical Center - Rizk Hospital | El Achrafiyé | Beirut | Lebanon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28756183 | Background | Mansour AG, Hariri E, Daaboul Y, Korjian S, El Alam A, Protogerou AD, Kilany H, Karam A, Stephan A, Bahous SA. Vitamin K2 supplementation and arterial stiffness among renal transplant recipients-a single-arm, single-center clinical trial. J Am Soc Hypertens. 2017 Sep;11(9):589-597. doi: 10.1016/j.jash.2017.07.001. Epub 2017 Jul 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin K2 (MK7) | Vitamin K2 (MK7) 360 mcg/day PO once daily for 8 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin K2 (MK7) | Vitamin K2 (MK7) 360 mcg/day PO once daily for 8 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Reduction From Baseline in Carotid-femoral Pulse Wave Velocity at 8 Weeks | Posted | Mean | Standard Error | m/s | 8 weeks |
|
|
10 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vitamin K2 (MK7) | Vitamin K2 (MK7) 360 mcg/day PO once daily for 8 weeks Vitamin K2 (MK7) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI symptoms | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sola Aoun Bahous | Lebanese American University | +961-1-200-800 | sola.bahous@lau.edu.lb |
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| ID | Term |
|---|---|
| D024482 | Vitamin K 2 |
| ID | Term |
|---|---|
| D014812 | Vitamin K |
| D009285 | Naphthoquinones |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| Change From Baseline in Blood Concentration of Dephosphorylated-uncarboxylated Matrix Gla Protein (Dp-ucMGP) at 8 Weeks | 8 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Transplantation duration | Mean | Standard Deviation | years |
|
|
| Secondary | Change From Baseline in Central Pressure by Ambulatory Hemodynamic Measurement (Mobil-O-Graph) at 8 Weeks | Not Posted | 8 weeks | Participants |
| Secondary | Change From Baseline in Augmentation Index by Ambulatory Hemodynamic Measurement (Mobil-O-Graph) at 8 Weeks | Not Posted | 8 weeks | Participants |
| Secondary | Change From Baseline in Blood Concentration of Dephosphorylated-uncarboxylated Matrix Gla Protein (Dp-ucMGP) at 8 Weeks | Not Posted | 8 weeks | Participants |
| 0 |
| 60 |
| 0 |
| 60 |
| 12 |
| 60 |
| Leg pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | Non-systematic Assessment |
|
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| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010836 | Phytol |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |