Vitamin D Deficiency Clinical Trial
Official title:
Evaluating the Effect of Solius UV Light Source in Improving Serum Levels of 25-hydroxyvitamin D in Vitamin D Deficient/ Insufficient Adults of Various Skin Types: A Feasibility Study
Verified date | December 2022 |
Source | Boston University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | December 12, 2021 |
Est. primary completion date | December 12, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 22 Years and older |
Eligibility | Inclusion Criteria: 1. Age at least 22 years old 2. Male or Female 3. Skin Type I-VI 4. Women of childbearing potential must be on birth control and not pregnant based on a negative pregnancy test at baseline. 5. Ability and Willingness to give informed consent and comply to protocol requirements 6. Serum total 25(OH)D < 30 ng/mL Exclusion Criteria: 1. Ongoing treatment with supplemental or pharmacological doses of vitamin D, vitamin D metabolites or analogues 2. Pregnant 3. History of underlying photosensitivity 4. Use of medications that cause a photosensitivity reaction (including but not limited to): tetracycline, tretinoin, amiodarone, doxycycline, naproxen, diphenhydramine, methotrexate, and hydrochlorothiazide 5. History of skin cancer 6. Plan to received significant sun exposure below the 33rd parallel during study 7. Used tanning or phototherapy devices within the last 30 days 8. Vitamin D supplement use of more than 600 IUs daily. 9. Systemic steroids use 10. H1 antihistamine use in the last 7 days 11. Diagnosed with light allergies (including but not limited to): actinic prurigo, polymorphous light eruption, or solar urticaria 12. Diagnosed with light sensitivities (including but not limited to): protoporphyria, photodermatitis, xeroderma pigmentosum, lupus erythematosus, chronic actinic dermatitis, or UV-sensitive syndrome |
Country | Name | City | State |
---|---|---|---|
United States | General Clinical Research Unit (GCRU) BU School of Medicine | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serum 25-hydroxyvitamin D | Serum 25-hydroxyvitamin D level at 4 weeks of intervention (the end of study) | Serum 25-hydroxyvitamin D at 4 weeks of intervention |
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