Status:
COMPLETED
Evaluating the Effect of SOLIUS UV Light Source in Improving Vitamin D Status
Lead Sponsor:
Boston University
Conditions:
Vitamin D Deficiency
Vitamin D Insufficiency
Eligibility:
All Genders
22+ years
Phase:
NA
Brief 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 type...
Detailed Description
Study enrollment Approximately 100 healthy adults will be enrolled ages 22 or older; both sexes, for vitamin D deficiency screening in order to enroll 80 adults with vitamin D deficiency/insufficienc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2023
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT04780776
Start Date
February 23 2022
End Date
November 2 2023
Last Update
October 22 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
BU School of Medicine
Boston, Massachusetts, United States, 02118