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Vitamin D is a commonly available essential prohormone humans need to regulate blood calcium and has recently emerged as potentially helpful in combating severe COVID-19. Despite its importance, some studies estimate as much as 40% of the US population is deficient in vitamin D. Most available vitamin D supplements have little absorption data and are nearly all softgels or capsules. This clinical trial is designed as a preliminary pharmacokinetics study to assess the absorbance of a nano liquid D3 supplement that can be taken as an oral spray once daily. Preliminary evidence suggests that this nano liquid D3 may be absorbed more readily than commercially available softgel dosage forms of D3. This randomized, double-blind, placebo-controlled trial will compare nano liquid D3 to commonly available D3 oral softgels and a placebo control group over the course of a thirty-one (31) day study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nano Liquid D3 | Experimental | Arm receiving Nano Liquid Vitamin D3 |
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| Softgel D3 | Active Comparator | Group receiving Softgel Vitamin D3 |
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| Placebo Control | Placebo Comparator | Liquid mixture, identical in process, taste, smell, and appearance to Nano Liquid D3, but containing no active ingredient (no Vitamin D3) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Softgel Vitamin D3 | Dietary Supplement | 5000IU vitamin D3 taken as single oral softgel once daily for 30 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in 25(OH)D Blood Serum Levels | Change in 25(OH)D blood serum levels in the test group taking 5,000 IU of Nano Liquid D3 daily after supplementation compared to the placebo control during the same time frame | 31 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melanie Schroeder, PharmD | Inspired Life Medical, Inc. | Principal Investigator |
| Noah B Goodson, PhD | The Scope Method, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inspired Life Medical Office | Le Sueur | Minnesota | 56058 | United States |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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Full blinding protocols employed to mask all participants, all those engaging with participants, and the PI for the duration of the study period.
| Nano Liquid Vitamin D3 | Dietary Supplement | 5000IU vitamin D3 taken as liquid oral spray once daily for 30 days |
|
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| 25(OH)D Blood Serum Test | Diagnostic Test | A sample of blood is drawn off and processed for 25(OH)D levels at baseline, after 15 days of supplementation, and after 30 days of supplementation |
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| Placebo Control | Other | Liquid oral spray once daily for 30 days. Solution identical in smell, taste, color, and production process to Nano Liquid D3, but containing no Vitamin D3. |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |