N/A
N=10
Solius UV Light Source in Improving Serum Levels of 25-hydroxyvitamin D
Vitamin D Deficiency · Vitamin D Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT04865432 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Serum 25-hydroxyvitamin D — 25.4 ng/nl
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- UVB treatment (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Boston University
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum 25-hydroxyvitamin D |
25.4 | — |
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.
Eligibility Criteria
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.
- 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
Data sourced from ClinicalTrials.gov (NCT04865432). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.