NCT04885803

Vitamin D Absorbance Study - Clinical Trial of the Absorbance of Nano Liquid D3

Vitamin D Absorbance Study - A Decentralized, Randomized, Double-blind, Placebo-controlled Clinical Trial of the Pharmacokinetics of Vitamin D3 Absorption From Softgel Supplements Compared to Nano Liquid D3 Supplements in Humans.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Inspired Life Medical, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Vitamin D Deficiency

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Softgel Vitamin D3	5000IU vitamin D3 taken as single oral softgel once daily for 30 days
DIETARY_SUPPLEMENT	Nano Liquid Vitamin D3	5000IU vitamin D3 taken as liquid oral spray once daily for 30 days
DIAGNOSTIC_TEST	25(OH)D Blood Serum 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
OTHER	Placebo Control	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.

Timeline

• Start date: 2021-03-26
• Primary completion: 2021-06-30
• Completion: 2021-07-30
• First posted: 2021-05-13
• Last updated: 2021-08-24

Locations

1 site across 1 country: United States