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

Vitamin D Deficiency Clinical Trial

— ViDAS  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04885803
• Other study ID #: Vitamin D Absorbance Study
• Status: Completed
• Phase: N/A
• Start date: March 26, 2021
• Est. completion date: July 30, 2021

Study information

• Verified date: August 2021
• Source: Inspired Life Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: July 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Adults, ages 18-70 years old

• Either male or female

• Taking less than 2,000 IU of vitamin D daily as a supplement during the 30 days before starting the study

• Ability to swallow a pill of typical size or a liquid less than 1 mL daily for 30 days

• Ability to speak, read, and understand English

• Access to smart phone or smart device with internet access for study-related communications

• Ability to do 3 at-home vitamin D finger prick blood tests on 3 separate days. The kits and supplies will be given to you.

• Ability to drop off finished blood tests at a UPS store or UPS drop box, or schedule a UPS pickup at your home, on each of the same days as you do the blood tests

Exclusion Criteria:

• Females who are pregnant

• Taking, on average, more than 2,000 IU of vitamin D daily within 30 days before the study

• Currently have COVID-19 infection

• History of COVID-19 infection or positive COVID-19 test in last 60 days

• People with a diagnosis of Cystic Fibrosis

• People with a diagnosis of Crohn's Disease

• People diagnosed with Celiac Disease

• People with known diagnosis or history of any kidney related disease Including, but not limited to: Chronic kidney disease; End stage renal disease; Polycystic kidney disease; Lupus nephritis; Kidney cancer, Alport syndrome; Amyloidosis; Goodpasture syndrome; and Wegener's granulomatosis

• People with known diagnosis or history of any liver related disease Including, but not limited to: Hepatitis A; Hepatitis B; Hepatitis C; Fatty liver disease; Cirrhosis of the liver; Liver cancer; Hemochromatosis; Wilson disease

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Softgel Vitamin D3
5000IU vitamin D3 taken as single oral softgel once daily for 30 days
• 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.

Locations

Country	Name	City	State
United States	Inspired Life Medical Office	Le Sueur	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Inspired Life Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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