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

NCT ID: NCT04885803

Last Updated: 2021-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-26
• Study Completion Date: 2021-07-30

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.

Conditions

Vitamin D Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Nano Liquid D3

Arm receiving Nano Liquid Vitamin D3

Group Type: EXPERIMENTAL

Nano Liquid Vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

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

25(OH)D Blood Serum Test

Intervention Type: 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

Softgel D3

Group receiving Softgel Vitamin D3

Group Type: ACTIVE_COMPARATOR

Softgel Vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

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

25(OH)D Blood Serum Test

Intervention Type: 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

Placebo Control

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

Group Type: PLACEBO_COMPARATOR

25(OH)D Blood Serum Test

Intervention Type: 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

Placebo Control

Intervention Type: 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.

Interventions

Softgel Vitamin D3

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

Intervention Type: DIETARY_SUPPLEMENT

Nano Liquid Vitamin D3

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

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: OTHER

Other Intervention Names

Cholecalciferol; Cholecalciferol; Vitamin D Blood Test; Nano Liquid Placebo

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Inspired Life Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melanie Schroeder, PharmD

Role: PRINCIPAL_INVESTIGATOR

Inspired Life Medical, Inc.

Noah B Goodson, PhD

Role: STUDY_DIRECTOR

The Scope Method, LLC

Locations

Inspired Life Medical Office

Le Sueur, Minnesota, United States

Countries

United States

Other Identifiers

Vitamin D Absorbance Study

Identifier Type: -

Identifier Source: org_study_id