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| Name | Class |
|---|---|
| Medical University of South Carolina | OTHER |
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The objective of this study is to evaluate and compare the bioequivalence between a single oral dose of vitamin D3 gummy vitamin versus vitamin D3 tablet in healthy adults.
The investigators hypothesize that the gummy and tablet preparations of vitamin D3 supplement will be biologically equivalent, as defined by the absence of a statistically significant difference in bioavailability measured as blood levels of vitamin D3 after administration of the same dose of gummy and tablet supplementation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitafusion Extra Strength Vitamin D3 Gummy | Experimental | Single oral dose of gummy vitamin D3 to monitor vitamin D blood levels |
|
| Nature Made Vitamin D3 Tablet | Active Comparator | Single oral dose of tablet vitamin D3 to monitor vitamin D blood levels |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitafusion Extra Strength Vitamin D | Dietary Supplement | Monitor Vitamin D blood levels |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Absorption | A comparison of mean absorption of the two vitamin formulations (gummy vs. tablet) | baseline, 3, 6, 10, 24 and 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Absorption Rate | A comparison of absorption rate across the two vitamin formulations (gummy vs. tablet) | 0 to 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Annahita Ghassemi | Church & Dwight Company, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Church & Dwight Co., Inc. | Princeton | New Jersey | 08543 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 19, 2021 | |
| Reset | May 11, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 19, 2021 | May 11, 2021 |
Randomized, cross-over, comparator-controlled
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