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
Verified date | November 2023 |
Source | Boston University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to evaluate the safety and effectiveness of the Solius Photobiological System in improving serum levels of 25-hydroxyvitamin D in vitamin D deficient/ insufficient adults of various skin types. The invetigators will conduct an 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 Photobiological System for 16 weeks.
Status | Completed |
Enrollment | 51 |
Est. completion date | October 20, 2023 |
Est. primary completion date | October 20, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age at least 18 years' old 2. Male or Female 3. Skin Type I-VI 4. Women of child bearing 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 at the screening 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 | BU School of Medicine | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Baseline serum 25-hydroxyvitamin D | Baseline | ||
Primary | Serum 25-hydroxyvitamin D at 4 weeks of intervention | Week 4 of the intervention | ||
Primary | Serum 25-hydroxyvitamin D at 8 weeks of intervention | Week 8 of the intervention | ||
Primary | Serum 25-hydroxyvitamin D at 12 weeks of intervention | Week 12 of the intervention | ||
Primary | Serum 25-hydroxyvitamin D at 16 weeks of intervention | Week 16 of the intervention | ||
Primary | Serum 25-hydroxyvitamin D at 1 week post-intervention | Week 1 post-intervention | ||
Primary | Serum 25-hydroxyvitamin D at 2 weeks post-intervention | Week 2 post-intervention | ||
Primary | Serum 25-hydroxyvitamin D at 3 weeks post-intervention | Week 3 post-intervention | ||
Primary | Serum 25-hydroxyvitamin D at 4 weeks post-intervention | Week 4 post-intervention |
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