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

Primary Purpose

Vitamin D Deficiency

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Softgel Vitamin D3
Nano Liquid Vitamin D3
25(OH)D Blood Serum Test
Placebo Control
Sponsored by
Inspired Life Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Vitamin D Deficiency

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Inspired Life Medical Office

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Nano Liquid D3

Softgel D3

Placebo Control

Arm Description

Arm receiving Nano Liquid Vitamin D3

Group receiving Softgel Vitamin D3

Liquid mixture, identical in process, taste, smell, and appearance to Nano Liquid D3, but containing no active ingredient (no Vitamin D3)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 6, 2021
Last Updated
August 23, 2021
Sponsor
Inspired Life Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04885803
Brief Title
Vitamin D Absorbance Study - Clinical Trial of the Absorbance of Nano Liquid D3
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 26, 2021 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
July 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inspired Life Medical, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Full blinding protocols employed to mask all participants, all those engaging with participants, and the PI for the duration of the study period.
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nano Liquid D3
Arm Type
Experimental
Arm Description
Arm receiving Nano Liquid Vitamin D3
Arm Title
Softgel D3
Arm Type
Active Comparator
Arm Description
Group receiving Softgel Vitamin D3
Arm Title
Placebo Control
Arm Type
Placebo Comparator
Arm Description
Liquid mixture, identical in process, taste, smell, and appearance to Nano Liquid D3, but containing no active ingredient (no Vitamin D3)
Intervention Type
Dietary Supplement
Intervention Name(s)
Softgel Vitamin D3
Other Intervention Name(s)
Cholecalciferol
Intervention Description
5000IU vitamin D3 taken as single oral softgel once daily for 30 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Nano Liquid Vitamin D3
Other Intervention Name(s)
Cholecalciferol
Intervention Description
5000IU vitamin D3 taken as liquid oral spray once daily for 30 days
Intervention Type
Diagnostic Test
Intervention Name(s)
25(OH)D Blood Serum Test
Other Intervention Name(s)
Vitamin D Blood Test
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Placebo Control
Other Intervention Name(s)
Nano Liquid Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in 25(OH)D Blood Serum Levels
Description
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
Time Frame
31 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melanie Schroeder, PharmD
Organizational Affiliation
Inspired Life Medical, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Noah B Goodson, PhD
Organizational Affiliation
The Scope Method, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Inspired Life Medical Office
City
Le Sueur
State/Province
Minnesota
ZIP/Postal Code
56058
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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