Vitamin D Absorbance Study - Clinical Trial of the Absorbance of Nano Liquid D3
ViDAS
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.
1 other identifier
interventional
114
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 26, 2021
CompletedFirst Submitted
Initial submission to the registry
May 6, 2021
CompletedFirst Posted
Study publicly available on registry
May 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2021
CompletedAugust 24, 2021
August 1, 2021
3 months
May 6, 2021
August 23, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
31 days
Study Arms (3)
Nano Liquid D3
EXPERIMENTALArm receiving Nano Liquid Vitamin D3
Softgel D3
ACTIVE COMPARATORGroup receiving Softgel Vitamin D3
Placebo Control
PLACEBO COMPARATORLiquid mixture, identical in process, taste, smell, and appearance to Nano Liquid D3, but containing no active ingredient (no Vitamin D3)
Interventions
5000IU vitamin D3 taken as single oral softgel once daily for 30 days
5000IU vitamin D3 taken as liquid oral spray once daily for 30 days
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
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Inspired Life Medical Office
Le Sueur, Minnesota, 56058, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Melanie Schroeder, PharmD
Inspired Life Medical, Inc.
- STUDY DIRECTOR
Noah B Goodson, PhD
The Scope Method, LLC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Full blinding protocols employed to mask all participants, all those engaging with participants, and the PI for the duration of the study period.
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2021
First Posted
May 13, 2021
Study Start
March 26, 2021
Primary Completion
June 30, 2021
Study Completion
July 30, 2021
Last Updated
August 24, 2021
Record last verified: 2021-08