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This study used the generally recognized as safe (GRAS) grade of Bacillus subtilis natto to produce Vitamin K2, Menaquinone-7(MK-7), via fermentation, for functional evaluation. There are four major objectives for this study: (1) bioavailability of calcium; (2) evaluation of bone density improvement; (3) evaluation of blood-vessel calcification and sclerosis improvement; (4) safety evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Vit K2+ Vit D3+ calcium carbonate (CaCO3) |
|
| B | Active Comparator | Vit K2+CaCO3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vit K2+ Vit D3+ calcium carbonate (CaCO3) | Dietary Supplement |
| ||
| Vit K2+CaCO3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Serum Calcium | at 4 hours after intake |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in urine calcium/creatinine ratio | at 4 hours after intake |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in serum Parathyroid hormone(PTH) | at 4 hour after intake |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shih-Li Su, MD | Changhua Christian Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhua Christian Hospital | Changhua | Taiwan | 500 | Taiwan |
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| ID | Term |
|---|---|
| D018761 | Multiple Endocrine Neoplasia Type 1 |
| ID | Term |
|---|---|
| D009377 | Multiple Endocrine Neoplasia |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Dietary Supplement |
|
| D009378 |
| Neoplasms, Multiple Primary |
| D009386 | Neoplastic Syndromes, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004700 | Endocrine System Diseases |