Skip to main content
OpenTrials
Completed

NCT Number: NCT04885803

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inspired Life Medical Office

Le Sueur, Minnesota, 56058, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Softgel Vitamin D3

Dietary Supplement

5000IU vitamin D3 taken as single oral softgel once daily for 30 days

Other names: Cholecalciferol

Nano Liquid Vitamin D3

Dietary Supplement

5000IU vitamin D3 taken as liquid oral spray once daily for 30 days

Other names: Cholecalciferol

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

Other names: Vitamin D Blood Test

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.

Other names: Nano Liquid Placebo

Primary outcomes

  1. Change in 25(OH)D Blood Serum Levels

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Inspired Life Medical, Inc.

Industry

Registry information

Official study 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.

Acronym: ViDAS

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 13, 2021
Registry last updated
Aug 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.