An interventional study of Softgel Vitamin D3 and Nano Liquid Vitamin D3 in Vitamin D Deficiency, sponsored by Inspired Life Medical, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-24.
Sponsored by Inspired Life Medical, Inc. · Not applicable, Interventional, and Other
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.
772 studies on the registry are indexed under Vitamin D Deficiency; 61 are open to participants now.
This study's enrollment of 114 is above the median of 77 across 564 interventional studies indexed under Vitamin D Deficiency.
Browse Vitamin D Deficiency studies →This is the only study on the registry with Inspired Life Medical, Inc. as lead sponsor.
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Exclusion Criteria:
Arm receiving Nano Liquid Vitamin D3
Dietary Supplement: Nano Liquid Vitamin D3 · Diagnostic Test: 25(OH)D Blood Serum Test
Group receiving Softgel Vitamin D3
Dietary Supplement: Softgel Vitamin D3 · Diagnostic Test: 25(OH)D Blood Serum Test
Liquid mixture, identical in process, taste, smell, and appearance to Nano Liquid D3, but containing no active ingredient (no Vitamin D3)
Diagnostic Test: 25(OH)D Blood Serum Test · Other: Placebo Control
5000IU vitamin D3 taken as single oral softgel once daily for 30 days
Also known as: Cholecalciferol
5000IU vitamin D3 taken as liquid oral spray once daily for 30 days
Also known as: Cholecalciferol
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
Also known as: Vitamin D Blood Test
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.
Also known as: Nano Liquid Placebo
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
Time frame: 31 days
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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