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

August 23, 2021 updated by: Inspired Life Medical, Inc.

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Le Sueur, Minnesota, United States, 56058
        • Inspired Life Medical Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nano Liquid D3
Arm receiving Nano Liquid Vitamin D3
Dietary supplement: Nano Liquid Vitamin D3
5000IU vitamin D3 taken as liquid oral spray once daily for 30 days
Other Names:
  • Cholecalciferol
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 Names:
  • Vitamin D Blood Test
Active Comparator: Softgel D3
Group receiving Softgel Vitamin D3
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 Names:
  • Vitamin D Blood Test
Dietary supplement: Softgel Vitamin D3
5000IU vitamin D3 taken as single oral softgel once daily for 30 days
Other Names:
  • Cholecalciferol
Placebo Comparator: Placebo Control
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
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
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.
Other Names:
  • Nano Liquid Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
31 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inspired Life Medical, Inc.

Investigators

  • Principal Investigator: Melanie Schroeder, PharmD, Inspired Life Medical, Inc.
  • Study Director: Noah B Goodson, PhD, The Scope Method, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2021

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

July 30, 2021

Study Registration Dates

First Submitted

May 6, 2021

First Submitted That Met QC Criteria

May 6, 2021

First Posted (Actual)

May 13, 2021

Study Record Updates

Last Update Posted (Actual)

August 24, 2021

Last Update Submitted That Met QC Criteria

August 23, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vitamin D Absorbance Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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