CompletedNot Applicable

Evaluating the Effect of SOLIUS UV Light Source in Improving Vitamin D Status

United States69 participantsStarted 2022-02-23

Plain-language 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. 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.

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. Ongoing treatment with supplemental or pharmacological doses of vitamin D, vitamin D metabolites or analogues

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Serum 25-Hydroxyvitamin D [25(OH)D]

Timeframe: Week 1, Week 21

Distribution of Participants by Vitamin D Deficiency Categories at Week 1

Timeframe: Week 1

Distribution of Participants by Vitamin D Deficiency Categories at Week 21

Timeframe: Week 21

Trial details

NCT IDNCT04780776

SponsorBoston University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-02

Results submitted2024-09-26

View on ClinicalTrials.gov More Vitamin D Deficiency trials