N/A
N=69
Evaluating the Effect of SOLIUS UV Light Source in Improving Vitamin D Status
Vitamin D Deficiency · Vitamin D Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT04780776 ↗Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Change in Serum 25-Hydroxyvitamin D [25(OH)D] — 10.14; -2.3 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- UVB treatment (Device); Sham comparator (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Boston University
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Serum 25-Hydroxyvitamin D [25(OH)D] |
10.14; -2.3 | — |
| PRIMARY Distribution of Participants by Vitamin D Deficiency Categories at Week 1 |
19; 9; 6; 10; 2; 1 | — |
| PRIMARY Distribution of Participants by Vitamin D Deficiency Categories at Week 21 |
3; 16; 13; 4; 11; 0 | — |
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.
Eligibility Criteria
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
- 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 (NCT04780776). 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.