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

NCT04885803 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2021-08-24

No results posted yet for this study

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.

Conditions

  • Vitamin D Deficiency

Interventions

DIETARY_SUPPLEMENT

Softgel Vitamin D3

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

DIETARY_SUPPLEMENT

Nano Liquid Vitamin D3

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

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

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.

Sponsors & Collaborators

  • Inspired Life Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Melanie Schroeder, PharmD · Inspired Life Medical, Inc.

  • Noah B Goodson, PhD · The Scope Method, LLC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-26
Primary Completion
2021-06-30
Completion
2021-07-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04885803 on ClinicalTrials.gov