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 range22 Years

SexALL

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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
✕. 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
✕. Used tanning or phototherapy devices within the last 30 days
✕. Vitamin D supplement use of more than 600 IUs daily

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