CompletedNot Applicable

Solius UV Light Source in Improving Serum Levels of 25-hydroxyvitamin D

United States10 participantsStarted 2021-08-24

Plain-language summary

This is a feasibility interventional study seeking to determine the safety and efficacy of the Solius Photobiologic System in increasing the serum levels of 25(OH)D in a vitamin D deficient/insufficient adult population.

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 childbearing 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

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

Serum 25-hydroxyvitamin D

Timeframe: Serum 25-hydroxyvitamin D at 4 weeks of intervention

Trial details

NCT IDNCT04865432

SponsorBoston University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-12

Results submitted2022-12-02

View on ClinicalTrials.gov More Vitamin D Deficiency trials