Vitamin D DeficiencyNCT04780776
Evaluating the Effect of SOLIUS UV Light Source in Improving Vitamin D Status
A study testing UVB treatment in people with Vitamin D Deficiency and Vitamin D Insufficiency, run by Boston University at 1 site in United States.
Trial summary
The aim of this study is to evaluate the safety and effectiveness of the SOLIUS System in improving serum levels of 25-hydroxyvitamin D in vitamin D deficient/ insufficient adults of various skin types. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Vitamin D Insufficiency
- What is being tested?
- UVB treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2022to 2 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age at least 22 years old
- Male or Female
- Skin Type I-VI
- Women of child bearing potential must be on birth control and not pregnant based on a negative pregnancy test at baseline.
- Ability and Willingness to give informed consent and comply to protocol requirements
- Serum total 25(OH)D < 30 ng/mL at the screening
Who cannot join
- Ongoing treatment with supplemental or pharmacological doses of vitamin D, vitamin D metabolites or analogues
- Pregnant
- History of underlying photosensitivity
- Use of medications that cause a photosensitivity reaction (including but not limited to): tetracycline, tretinoin, amiodarone, doxycycline, naproxen, diphenhydramine, methotrexate, and hydrochlorothiazide
- History of skin cancer
- Plan to received significant sun exposure below the 33rd parallel during study
Show all 12Show fewer
- Used tanning or phototherapy devices within the last 30 days
- Vitamin D supplement use of more than 600 IUs daily
- Systemic steroids use
- H1 antihistamine use in the last 7 days
- Diagnosed with light allergies (including but not limited to): actinic prurigo, polymorphous light eruption, or solar urticaria
- Diagnosed with light sensitivities (including but not limited to): protoporphyria, photodermatitis, xeroderma pigmentosum, lupus erythematosus, chronic actinic dermatitis, or UV-sensitive syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effect of SOLIUS UV Light Source in Improving Serum Levels of 25-hydroxyvitamin D in Vitamin D Deficient/ Insufficient Adults of Various Skin Types
The aim of this study is to evaluate the safety and effectiveness of the SOLIUS System in improving serum levels of 25-hydroxyvitamin D in vitamin D deficient/ insufficient adults of various skin types.
The investigators will conduct a double-blinded randomized clinical trial in 100 adults to compare the changes in serum 25-hydroxyvitamin D levels between subjects who received and do not receive weekly exposures to Ultraviolet B Radiation (UVB) generated by the SOLIUS System for 16 weeks.
Read the detailed description
Study enrollment
Approximately 100 healthy adults will be enrolled ages 22 or older; both sexes, for vitamin D deficiency screening in order to enroll 80 adults with vitamin D deficiency/insufficiency (serum 25-hydroxyvitamin D <30 ng/mL). Participants will be randomized 1:1 into two groups: 40 adults for treatment arm who will receive weekly exposures of ultraviolet radiation generated by the SOLIUS System, and 40 adults for sham comparator arm.
Study procedure
The treatment group that will be exposed to the SOLIUS System will first undergo an evaluation of each individual's sensitivity to the SOLIUS System UVB using the device titration system for the first 5 weeks. Once the UVB dose is determined during the 5 weeks, the subjects will be enrolled in a 16-week study where they will be exposed to their individualized dose. For the sham comparator group, they will undergo the procedures as the treated group with the exception that the SOLIUS System will only be turned on to emit visible radiation. At these visits, each subject assigned into both groups will be asked questions about consumption of vitamin D, sun exposure, and whether he/she has had any adverse changes in his/her health. Serum 25-hydroxyvitamin D levels will be measured at baseline and monthly, and the levels will be analyzed to compare between those who receive and who do not receive the UVB radiation intervention for baseline and during the 16-week treatment period. After the 16-week intervention, participants will be asked to return to the study site weekly for measurement of serum 25-hydroxyvitamin D for 4 weeks. Serum 25(OH)D levels will be determined using the Liquid Chromatography with tandem mass spectrometry (LC/MS/MS) method. Safety will be monitored by interviewing the participants after each UVB exposure for any adverse events, including erythema or any other skin reactions.
- Conditions
- Vitamin D Deficiency, Vitamin D Insufficiency
- Being tested
- UVB treatment, Sham comparator
- Keywords
- Vitamin D, Ultraviolet B radiation, SOLIUS System
- 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.
UVB treatmentDevice
5 weeks of UVB titration to determine individual's UVB sensitivity followed by 16 weeks of UVB exposure intervention
Sham comparatorDevice
5+16 weeks of visible light exposure
| Study group | Role | What they receive |
|---|---|---|
| UVB treatment arm | Experimental | The treatment group will first undergo an evaluation of each individual's sensitivity to the SOLIUS System UVB using the device titration system for the first 5 weeks. Once the UVB dose is determined during the 5 weeks, the subjects will be enrolled in a 16-week study where they will be exposed to their individualized dose. Receives: Device: UVB treatment |
| Sham comparator arm | Sham comparator | The sham comparator group will undergo the procedures as the treatment group with the exception that the SOLIUS System will only be turned on to emit visible radiation. Receives: Device: Sham comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum 25-Hydroxyvitamin D [25(OH)D]
This outcome measures the change in serum 25-hydroxyvitamin D [25(OH)D] concentrations in participants from Week 1 to the end of the intervention period Week 21.
Measured: Week 1, Week 21
Distribution of Participants by Vitamin D Deficiency Categories at Week 1
The three vitamin D categories are defined as: Deficient - <20 ng/mL 25(OH)D, Insufficient - 21-29 ng/mL 25(OH)D, Sufficient - 30-100 ng/mL 25(OH)D.
Measured: Week 1
Distribution of Participants by Vitamin D Deficiency Categories at Week 21
The three vitamin D categories are defined as: Deficient - <20 ng/mL 25(OH)D, Insufficient - 21-29 ng/mL 25(OH)D, Sufficient - 30-100 ng/mL 25(OH)D.
Measured: Week 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start23 Feb 2022
- Primary completion2 Nov 2023
- Study completion2 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael F Holick, MD PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780776
- Sponsor's protocol ID
- H-40850
- Status last verified
- Sep 2024
- First submitted
- 26 Feb 2021
- Last updated
- 22 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of SOLIUS UV Light Source in Improving Serum Levels of 25-hydroxyvitamin D in Vitamin D Deficient/ Insufficient Adults of Various Skin Types
- ClinicalTrials.gov ID
- NCT04780776
- Acronym / sponsor ID
- H-40850
- Conditions
- Vitamin D Deficiency, Vitamin D Insufficiency
- Keywords
- Vitamin D, Ultraviolet B radiation, SOLIUS System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 2 Nov 2023 (actual)
- Study completion
- 2 Nov 2023 (actual)
- First posted
- 4 Mar 2021 (actual)
- Results
- Posted 22 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the safety and effectiveness of the SOLIUS System in improving serum levels of 25-hydroxyvitamin D in vitamin D deficient/ insufficient adults of various skin types.
The investigators will conduct a double-blinded randomized clinical trial in 100 adults to compare the changes in serum 25-hydroxyvitamin D levels between subjects who received and do not receive weekly exposures to Ultraviolet B Radiation (UVB) generated by the SOLIUS System for 16 weeks.
Detailed description
Study enrollment
Approximately 100 healthy adults will be enrolled ages 22 or older; both sexes, for vitamin D deficiency screening in order to enroll 80 adults with vitamin D deficiency/insufficiency (serum 25-hydroxyvitamin D <30 ng/mL). Participants will be randomized 1:1 into two groups: 40 adults for treatment arm who will receive weekly exposures of ultraviolet radiation generated by the SOLIUS System, and 40 adults for sham comparator arm.
Study procedure
The treatment group that will be exposed to the SOLIUS System will first undergo an evaluation of each individual's sensitivity to the SOLIUS System UVB using the device titration system for the first 5 weeks. Once the UVB dose is determined during the 5 weeks, the subjects will be enrolled in a 16-week study where they will be exposed to their individualized dose. For the sham comparator group, they will undergo the procedures as the treated group with the exception that the SOLIUS System will only be turned on to emit visible radiation. At these visits, each subject assigned into both groups will be asked questions about consumption of vitamin D, sun exposure, and whether he/she has had any adverse changes in his/her health. Serum 25-hydroxyvitamin D levels will be measured at baseline and monthly, and the levels will be analyzed to compare between those who receive and who do not receive the UVB radiation intervention for baseline and during the 16-week treatment period. After the 16-week intervention, participants will be asked to return to the study site weekly for measurement of serum 25-hydroxyvitamin D for 4 weeks. Serum 25(OH)D levels will be determined using the Liquid Chromatography with tandem mass spectrometry (LC/MS/MS) method. Safety will be monitored by interviewing the participants after each UVB exposure for any adverse events, including erythema or any other skin reactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UVB treatment arm | Experimental | Device: UVB treatmentThe treatment group will first undergo an evaluation of each individual's sensitivity to the SOLIUS System UVB using the device titration system for the first 5 weeks. Once the UVB dose is determined during the 5 weeks, the subjects will be enrolled in a 16-week study where they will be exposed to their individualized dose. |
| Sham comparator arm | Sham comparator | Device: Sham comparatorThe sham comparator group will undergo the procedures as the treatment group with the exception that the SOLIUS System will only be turned on to emit visible radiation. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age at least 22 years old
- Male or Female
- Skin Type I-VI
- Women of child bearing potential must be on birth control and not pregnant based on a negative pregnancy test at baseline.
- Ability and Willingness to give informed consent and comply to protocol requirements
Key exclusion criteria (12 listed)
- Ongoing treatment with supplemental or pharmacological doses of vitamin D, vitamin D metabolites or analogues
- Pregnant
- History of underlying photosensitivity
- Use of medications that cause a photosensitivity reaction (including but not limited to): tetracycline, tretinoin, amiodarone, doxycycline, naproxen, diphenhydramine, methotrexate, and hydrochlorothiazide
- History of skin cancer
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 |
|---|---|---|
| UVB treatment5 weeks of UVB titration to determine individual's UVB sensitivity followed by 16 weeks of UVB exposure intervention | Device | UVB treatment arm |
| Sham comparator5+16 weeks of visible light exposure | Device | Sham comparator arm |
Primary outcome
Change in Serum 25-Hydroxyvitamin D [25(OH)D]
Time frame: Week 1, Week 21
This outcome measures the change in serum 25-hydroxyvitamin D [25(OH)D] concentrations in participants from Week 1 to the end of the intervention period Week 21.
Distribution of Participants by Vitamin D Deficiency Categories at Week 1
Time frame: Week 1
The three vitamin D categories are defined as: Deficient - <20 ng/mL 25(OH)D, Insufficient - 21-29 ng/mL 25(OH)D, Sufficient - 30-100 ng/mL 25(OH)D.
Distribution of Participants by Vitamin D Deficiency Categories at Week 21
Time frame: Week 21
The three vitamin D categories are defined as: Deficient - <20 ng/mL 25(OH)D, Insufficient - 21-29 ng/mL 25(OH)D, Sufficient - 30-100 ng/mL 25(OH)D.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Michael F Holick, MD PhD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UVB treatment in people with Vitamin D Deficiency and Vitamin D Insufficiency, run by Boston University 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 6 inclusion and 12 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 22 Oct 2024. 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?
Yes. Results are posted in the registry (first posted 22 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Serum 25-Hydroxyvitamin D [25(OH)D] (time frame: Week 1, Week 21). The study lists 3 primary outcomes in all. 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 22 Oct 2024.