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

Not Applicable

Completed

• Conditions: Vitamin D Deficiency
• Interventions: Dietary Supplement: Softgel Vitamin D3; Dietary Supplement: Nano Liquid Vitamin D3; Diagnostic Test: 25(OH)D Blood Serum Test; Other: Placebo Control

• Registration Number: NCT04885803
• Lead Sponsor: Inspired Life Medical, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-26
• Study First Submitted: 2021-05-06
• Study First Submitted QC: 2021-05-06
• Study First Posted: 2021-05-13
• Primary Completion: 2021-06-30
• Study Completion: 2021-07-30
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Softgel D3	Softgel Vitamin D3	Group receiving Softgel Vitamin D3
Nano Liquid D3	Nano Liquid Vitamin D3	Arm receiving Nano Liquid Vitamin D3
Nano Liquid D3	25(OH)D Blood Serum Test	Arm receiving Nano Liquid Vitamin D3
Softgel D3	25(OH)D Blood Serum Test	Group receiving Softgel Vitamin D3
Placebo Control	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)
Placebo Control	Placebo Control	Liquid mixture, identical in process, taste, smell, and appearance to Nano Liquid D3, but containing no active ingredient (no Vitamin D3)

Primary Outcome Measures

Name	Time	Method
Change in 25(OH)D Blood Serum Levels	31 days	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

Trial Locations

Locations (1)

Inspired Life Medical Office; 🇺🇸 Le Sueur, Minnesota, United States