Vitamin D DeficiencyViDASNCT04885803
Vitamin D Absorbance Study - Clinical Trial of the Absorbance of Nano Liquid D3
A study testing Softgel Vitamin D3, Nano Liquid Vitamin D3 and 25(OH)D Blood Serum Test in people with Vitamin D Deficiency, run by Inspired Life Medical, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Softgel Vitamin D3, Nano Liquid Vitamin D3 and 25(OH)D Blood Serum Test
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2021to 30 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Inspired Life Medical Office
Le Sueur, Minnesota, 56058
About this study
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.
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
- Being tested
- Softgel Vitamin D3, Nano Liquid Vitamin D3, 25(OH)D Blood Serum Test, Placebo Control
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Softgel Vitamin D3Dietary supplement
Also called Cholecalciferol
5000IU vitamin D3 taken as single oral softgel once daily for 30 days
Nano Liquid Vitamin D3Dietary supplement
Also called Cholecalciferol
5000IU vitamin D3 taken as liquid oral spray once daily for 30 days
25(OH)D Blood Serum TestDiagnostic test
Also called Vitamin D Blood 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 ControlOther
Also called Nano Liquid Placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| Nano Liquid D3 | Experimental | Arm receiving Nano Liquid Vitamin D3 Receives: Dietary Supplement: Nano Liquid Vitamin D3; Diagnostic Test: 25(OH)D Blood Serum Test |
| Softgel D3 | Active comparator | Group receiving Softgel Vitamin D3 Receives: Dietary Supplement: Softgel Vitamin D3; Diagnostic Test: 25(OH)D Blood Serum Test |
| Placebo Control | Placebo comparator | Liquid mixture, identical in process, taste, smell, and appearance to Nano Liquid D3, but containing no active ingredient (no Vitamin D3) Receives: Diagnostic Test: 25(OH)D Blood Serum Test; Other: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 31 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start26 Mar 2021
- Primary completion30 Jun 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inspired Life Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Melanie Schroeder, PharmD, Principal investigator, Inspired Life Medical, Inc.Noah B Goodson, PhD, Study director, The Scope Method, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885803
- Sponsor's protocol ID
- Vitamin D Absorbance Study
- Acronym
- ViDAS
- Status last verified
- Aug 2021
- First submitted
- 6 May 2021
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04885803
- Acronym / sponsor ID
- ViDAS / Vitamin D Absorbance Study
- Conditions
- Vitamin D Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Inspired Life Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 13 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nano Liquid D3 | Experimental | Dietary Supplement: Nano Liquid Vitamin D3, Diagnostic Test: 25(OH)D Blood Serum TestArm receiving Nano Liquid Vitamin D3 |
| Softgel D3 | Active comparator | Dietary Supplement: Softgel Vitamin D3, Diagnostic Test: 25(OH)D Blood Serum TestGroup receiving Softgel Vitamin D3 |
| Placebo Control | Placebo comparator | Diagnostic Test: 25(OH)D Blood Serum Test, Other: Placebo ControlLiquid mixture, identical in process, taste, smell, and appearance to Nano Liquid D3, but containing no active ingredient (no Vitamin D3) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Softgel Vitamin D3Also: Cholecalciferol5000IU vitamin D3 taken as single oral softgel once daily for 30 days | Dietary supplement | Softgel D3 |
| Nano Liquid Vitamin D3Also: Cholecalciferol5000IU vitamin D3 taken as liquid oral spray once daily for 30 days | Dietary supplement | Nano Liquid D3 |
| 25(OH)D Blood Serum TestAlso: Vitamin D Blood TestA 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 | Diagnostic test | Nano Liquid D3, Placebo Control, Softgel D3 |
| Placebo ControlAlso: Nano Liquid PlaceboLiquid 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 | Placebo Control |
Primary outcome
Change in 25(OH)D Blood Serum Levels
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melanie Schroeder, PharmD principal investigator
Inspired Life Medical, Inc.
Noah B Goodson, PhD study director
The Scope Method, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Softgel Vitamin D3, Nano Liquid Vitamin D3 and 25(OH)D Blood Serum Test in people with Vitamin D Deficiency, run by Inspired Life Medical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 25(OH)D Blood Serum Levels (time frame: 31 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.