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

Sponsor
Inspired Life Medical, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04885803
Collaborator
(none)
114
Enrollment
1
Location
3
Arms
4.1
Actual Duration (Months)
27.5
Patients Per Site Per Month

Study Details

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

  1. 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.
Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Softgel Vitamin D3
  • Dietary Supplement: Nano Liquid Vitamin D3
  • Diagnostic Test: 25(OH)D Blood Serum Test
  • Other: Placebo Control
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
114 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
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.
Primary Purpose:
Other
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.
Actual Study Start Date :
Mar 26, 2021
Actual Primary Completion Date :
Jun 30, 2021
Actual Study Completion Date :
Jul 30, 2021

Arms and Interventions

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

    Dietary Supplement: Softgel Vitamin D3
    5000IU vitamin D3 taken as single oral softgel 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

    		•
    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Inspired Life Medical Office Le Sueur Minnesota United States 56058

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Inspired Life Medical, Inc.
    ClinicalTrials.gov Identifier:
    NCT04885803
    Other Study ID Numbers:
    • Vitamin D Absorbance Study
    First Posted:
    May 13, 2021
    Last Update Posted:
    Aug 24, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Vitamin D Deficiency
    Vitamin D
    Ergocalciferols
    Cholecalciferol
    Vitamins

    Study Results

    No Results Posted as of Aug 24, 2021